U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy.
All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018.
" Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory.
" Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter.
" Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form.
o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Rod, fixation, intramedullary and accessories - Product Code HSB
Cause
Potential failure of sterile packaging seal.
Action
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy.
All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018.
" Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory.
" Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter.
" Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form.
o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Rod, fixation, intramedullary and accessories - Product Code HSB
Cause
Potential failure of sterile packaging seal.
Action
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy.
All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018.
" Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory.
" Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter.
" Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form.
o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Rod, fixation, intramedullary and accessories - Product Code HSB
Cause
Potential failure of sterile packaging seal.
Action
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy.
All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018.
" Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory.
" Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter.
" Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form.
o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy.
All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018.
" Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory.
" Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter.
" Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form.
o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy.
All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018.
" Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory.
" Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter.
" Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form.
o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Guide, surgical, instrument - Product Code FZX
Cause
Potential failure of sterile packaging seal.
Action
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy.
All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018.
" Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory.
" Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter.
" Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form.
o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
soft tissue fixation screw - Product Code HWC
Cause
Specific lots of the device were overexposed during eto sterilization. this may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Action
The recalling firm issued letters to Distributors as well as to affected Risk Managers and Surgeons.
Distributors were instructed to ensure affected team members are aware of the contents of the recall notification, locate and quarantine affected product in inventory, return all affected product from distributorship and from affected hospitals, and submit a list of any additional customer accounts that were not notified of the recall to the recalling firm.
Risk Managers were instructed to ensure affected personnel are aware of the contents of the recall notification, quarantine all affected product, and complete the included Certificate of Acknowledgement and return to the recalling firm, even if no affected products were present at the facility. Surgeons were instructed to review the notification and return the completed Certificate of Acknowledgement.
Customers' questions and concerns were directed to the recalling firm's customer service at 574-371-3071, 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy.
All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018.
" Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory.
" Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter.
" Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form.
o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Cause
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers.
Action
Recall initiated 02/23/2018
Firm released an update software (SW) version (V), 1.12.1, which corrects the behavior. A Mandatory Update (MU) campaign was launched to install the new SW V on all systems, whether or not they are impacted by this behavior. The MU campaign will be tracked to 100% completion globally.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy.
All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018.
" Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory.
" Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter.
" Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form.
o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy.
All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018.
" Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory.
" Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter.
" Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form.
o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Zimmer Biomet will conduct this recall to distributors and hospital risk managers that have consigned inventory or inventory within their territory, as well as distributors that have accounts in their territory that received a direct sale of affected products. Affected products that remain in consignment will be referred to as fielded inventory throughout the remainder of this recall strategy.
All distributors will be notified via email. Hospital risk managers, as well as distributors, with direct sales and/or fielded inventory, will be notified via courier. Notification letters were sent to customers on March 26, 2018.
" Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory.
" Distributors will return on-hand product to Zimmer Biomet and ensure all affected fielded inventory is accounted for using the form provided in the letter.
" Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include:
o Assisting the Zimmer Biomet sales representative with the quarantine of fielded inventory and completion and return of the Attachment 1 form.
o Complete and return Attachment 1 (Acknowledgement of Responsibility) to email address provided.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
soft tissue fixation screw - Product Code HWC
Cause
Specific lots of the device were overexposed during eto sterilization. this may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Action
The recalling firm issued letters to Distributors as well as to affected Risk Managers and Surgeons.
Distributors were instructed to ensure affected team members are aware of the contents of the recall notification, locate and quarantine affected product in inventory, return all affected product from distributorship and from affected hospitals, and submit a list of any additional customer accounts that were not notified of the recall to the recalling firm.
Risk Managers were instructed to ensure affected personnel are aware of the contents of the recall notification, quarantine all affected product, and complete the included Certificate of Acknowledgement and return to the recalling firm, even if no affected products were present at the facility. Surgeons were instructed to review the notification and return the completed Certificate of Acknowledgement.
Customers' questions and concerns were directed to the recalling firm's customer service at 574-371-3071, 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Clinical chemistry Electrode, ion specific, sodium - Product Code JGS
Cause
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers.
Action
Recall initiated 02/23/2018
Firm released an update software (SW) version (V), 1.12.1, which corrects the behavior. A Mandatory Update (MU) campaign was launched to install the new SW V on all systems, whether or not they are impacted by this behavior. The MU campaign will be tracked to 100% completion globally.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
soft tissue fixation screw - Product Code HWC
Cause
Specific lots of the device were overexposed during eto sterilization. this may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Action
The recalling firm issued letters to Distributors as well as to affected Risk Managers and Surgeons.
Distributors were instructed to ensure affected team members are aware of the contents of the recall notification, locate and quarantine affected product in inventory, return all affected product from distributorship and from affected hospitals, and submit a list of any additional customer accounts that were not notified of the recall to the recalling firm.
Risk Managers were instructed to ensure affected personnel are aware of the contents of the recall notification, quarantine all affected product, and complete the included Certificate of Acknowledgement and return to the recalling firm, even if no affected products were present at the facility. Surgeons were instructed to review the notification and return the completed Certificate of Acknowledgement.
Customers' questions and concerns were directed to the recalling firm's customer service at 574-371-3071, 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
soft tissue fixation screw - Product Code HWC
Cause
Specific lots of the device were overexposed during eto sterilization. this may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Action
The recalling firm issued letters to Distributors as well as to affected Risk Managers and Surgeons.
Distributors were instructed to ensure affected team members are aware of the contents of the recall notification, locate and quarantine affected product in inventory, return all affected product from distributorship and from affected hospitals, and submit a list of any additional customer accounts that were not notified of the recall to the recalling firm.
Risk Managers were instructed to ensure affected personnel are aware of the contents of the recall notification, quarantine all affected product, and complete the included Certificate of Acknowledgement and return to the recalling firm, even if no affected products were present at the facility. Surgeons were instructed to review the notification and return the completed Certificate of Acknowledgement.
Customers' questions and concerns were directed to the recalling firm's customer service at 574-371-3071, 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
soft tissue fixation screw - Product Code HWC
Cause
Specific lots of the device were overexposed during eto sterilization. this may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Action
The recalling firm issued letters to Distributors as well as to affected Risk Managers and Surgeons.
Distributors were instructed to ensure affected team members are aware of the contents of the recall notification, locate and quarantine affected product in inventory, return all affected product from distributorship and from affected hospitals, and submit a list of any additional customer accounts that were not notified of the recall to the recalling firm.
Risk Managers were instructed to ensure affected personnel are aware of the contents of the recall notification, quarantine all affected product, and complete the included Certificate of Acknowledgement and return to the recalling firm, even if no affected products were present at the facility. Surgeons were instructed to review the notification and return the completed Certificate of Acknowledgement.
Customers' questions and concerns were directed to the recalling firm's customer service at 574-371-3071, 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
soft tissue fixation screw - Product Code HWC
Cause
Specific lots of the device were overexposed during eto sterilization. this may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Action
The recalling firm issued letters to Distributors as well as to affected Risk Managers and Surgeons.
Distributors were instructed to ensure affected team members are aware of the contents of the recall notification, locate and quarantine affected product in inventory, return all affected product from distributorship and from affected hospitals, and submit a list of any additional customer accounts that were not notified of the recall to the recalling firm.
Risk Managers were instructed to ensure affected personnel are aware of the contents of the recall notification, quarantine all affected product, and complete the included Certificate of Acknowledgement and return to the recalling firm, even if no affected products were present at the facility. Surgeons were instructed to review the notification and return the completed Certificate of Acknowledgement.
Customers' questions and concerns were directed to the recalling firm's customer service at 574-371-3071, 8AM-5PM EST, Monday through Friday. Alternatively, questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Clinical chemistry Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Cause
When more than one immunoassay analyzer is connected to a single solution system, reporting and conversion factors may not be applied to all analyzers.
Action
Recall initiated 02/23/2018
Firm released an update software (SW) version (V), 1.12.1, which corrects the behavior. A Mandatory Update (MU) campaign was launched to install the new SW V on all systems, whether or not they are impacted by this behavior. The MU campaign will be tracked to 100% completion globally.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Notes supplémentaires dans les données
Tray, surgical, needle - Product Code FSH
Cause
The integrity of the sterile packaging is potentially compromised.
Action
On 2/23/2017, firm notified customers of recall via mailed letter. The letter included a recall response form. Customers were directed to either return the affected product along with the response form or destroy it and return the response form, indicating the product had been destroyed. All affected product will be destroyed.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Products do not meet the labeled sterility claim of a sterility assurance level (sal) 10-6.
Action
Immediately review your inventory for the specific Catalog (Ref) and lot numbers, and quarantine product subject to the recall. Immediately discontinue the distribution of the affected product.
If you have inventory of the recalled product, please complete the attached Business Response Form and return the recalled product following the enclosed packing instruction. This is required so that BD may process your product replacement.
If you do not have the recalled product, please complete the attached Business Response Form as well so that BD receives an acknowledgement of your receipt of this recall notification
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Products do not meet the labeled sterility claim of a sterility assurance level (sal) 10-6.
Action
Immediately review your inventory for the specific Catalog (Ref) and lot numbers, and quarantine product subject to the recall. Immediately discontinue the distribution of the affected product.
If you have inventory of the recalled product, please complete the attached Business Response Form and return the recalled product following the enclosed packing instruction. This is required so that BD may process your product replacement.
If you do not have the recalled product, please complete the attached Business Response Form as well so that BD receives an acknowledgement of your receipt of this recall notification
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Products do not meet the labeled sterility claim of a sterility assurance level (sal) 10-6.
Action
Immediately review your inventory for the specific Catalog (Ref) and lot numbers, and quarantine product subject to the recall. Immediately discontinue the distribution of the affected product.
If you have inventory of the recalled product, please complete the attached Business Response Form and return the recalled product following the enclosed packing instruction. This is required so that BD may process your product replacement.
If you do not have the recalled product, please complete the attached Business Response Form as well so that BD receives an acknowledgement of your receipt of this recall notification
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
The incorrect resistor has been used in affected core m2 imaging systems, which causes noise and results in an overly bright ivus image.
Action
Customers were notified on 03/21/2018. U.S. customers were notified via hand-delivered Urgent Medical Device Recall letters; foreign customer letters were mailed. The letter identified the affected device and the reason for the recall. Instructions included to stop usage of the device and to call remote support at 1-800-228-4728, to schedule a visit to replace the affected device. Customers were instructed to complete and return the customer response form or to provide the form to Philips representatives. Customers were also instructed to provide copies of the recall notification to all personnel within their organization who handled this device.