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
Syringe, piston - Product Code FMF
Cause
The stopper of the 10ml bd luer-lok syringe is not properly seated in the syringe.
Action
BD sent an Urgent Product Advisory Notice letter dated 12/19/2014. The letter identified the affected product, problem and actions to be taken. Customers are advised of the issue with the product and should notify their customers. The attached Product Advisory Response Form should be completed and faxed to 1-866-551-2707. Questions can be directed to 1-866-367-4703.
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
Heparin, vascular access flush - Product Code NZW
Cause
The lot failed ph specification.
Action
Fresenius sent an URGENT DRUG RECALL Letter dated December 19, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
1. Examine their stock immediately to determine if they have any product from the affected lot. If the consignee is a distributor, immediately notify your customers that have been shipped or may have been shipped this product/lot of this recall and direct them to discontinue distributing or dispensing the affected lot. Please have them prepare to return the product to Fresenius Kabi as instructed in the Urgent Product Recall Response Form. Your customers may retrieve the recall letter and response form at http://www.fresenius-kabi.us /products/pharmaceutical-products/product-updates.html.
2. If you have the affected lot available, immediately discontinue distributing or dispensing the lot, and return all units to Fresenius Kabi ,via FedEx Ground, using the enclosed return goods label and packing slip. A FedEx Ground label
can be obtained by checking the box and noting your mailing address on the enclosed Urgent Product Recall Response Form. It will be mailed to the consignee upon receiving the request. A credit memo will be issued covering the quantity of the return to Fresenius Kabi.
3. PLEASE COMPLETE THE ENCLOSED "URGENT PRODUCT RECALL RESPONSE FORM" AND SEND IT BACK TO US IMMEDIATELY VIA EMAIL OR FAX AT 1-708-649-8630.
Use the following contact phone numbers as appropriate. Hours of operation: Monday through Friday 8:00 am to 5:00 pm CST: QA Department: (866) 716-2459 for information on how to return product; Vigilance & Medical Affairs: 1(800) 551-7176 for clinical/technical information/Adverse Events (ADE's) reporting.
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.
Carefusion is recalling the smartsite low sorbing infusion set due to disconnection and leakage issues.
Action
CareFusion sent an Urgent Medical Device Recall Notification letter dated January 13, 2015, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return to CareFusion the recall response card. Customers with questions were instructed to CareFusion: Recall related questions, (888) 562-6018; Adverse Event Reports, (888) 812-3266; Technical Questions regarding the Alaris System, (888) 812-3229.
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
Dispenser, liquid medication - Product Code KYX
Cause
Self-righting luer tip caps were manufactured and shipped with a missing latex symbol on both single and case labels.
Action
Baxter sent an Safety Alert letter dated January 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Baxter is requesting that you take the following actions:
1.Complete the enclosed customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com. Returning the customer reply form promptly will prevent you from receiving repeat notices.
2. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action.
Action to be taken if you are an end-user and purchased product from a distributor or reseller:
1. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action.
2. Follow your supplier's reply process. Please do not return the customer reply form to Baxter.
Action to be taken if you are a distributor:
If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please notify your customers of this Safety Alert in accordance with your customary procedures. Further information and support
For general questions regarding this communication, contact The Center for One Baxter at 800-422-9837, Monday through Friday, between the hours of 8:00 AM and 5:00 PM Central Time.
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
Cover, barrier, protective - Product Code MMP
Cause
If the patient sits on either wing, not squarely on the center section of the stretcher lift, tipping and injury to the operator or patient could result. the device manual was updated with an additional warning statement.
Action
Beginning on 1/30/2015, the recalling firm sent letters via certified mail to their customers informing them of the change to the stretcher manual along with a revised manual which incorporated those changes. For questions regarding this recall call 402-694-5003.
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
Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Cause
Foreign material found within the kits. the foreign material, white or black particles and/or thread, is visible and can beidentified by the user.
Action
An urgent Medical Device Recall Notification, dated January 2, 2015, was sent to end users requesting they check their inventory and return affected product per Arrow's instructions.
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
Wrap, sterilization - Product Code FRG
Cause
Advanced sterilization products (asp) is recalling the tyvek rolls with sterrad chemical indicator because they were shipped to customers after its expiration date of may 18, 2013.
Action
A customer notification letter was sent on 12/24/14 to all customers who purchased the expired Tyvek Rolls with STERRAD Chemical Indicator. The letter informs the customers of the problems identified and the actions to be taken.
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.
Shaft breaks so that adequate patient specimen sample cannot be obtained.
Action
Consignees were initially notified of the recall via phone on 12/23/2014 and 12/29/2014. They were informed that the product may have been over exposed to gamma radiation, resulting in brittle sticks. They were instructed to not use the product for patient sampling and to return any product remaining in inventory to Puritan.
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
Pump, infusion - Product Code FRN
Cause
Cme america is recalling the bodyguard and bodyguard 323 infusion pumps due to the potential for an over delivery.
Action
CME America sent an "Urgent Medical Device Recall" letter dated January 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Required Action for Users: To date there have been no reports of adverse events or serious injury. However, there is the potential for serious injury or death. CME America recommends that you DO NOT use the BodyGuard 323 pump for PCA infusion. If your devices are currently in use, be sure that the programmed parameters DO NOT involve a patient controlled bolus dose less than 0.1 miln volume (translated into meg or mg).
Follow-up Actions by CME America: CME America has identified the root cause of this issue and is recommending installation of a new version of software, USA36B4, for affected BodyGuard 323 infusion pumps. This software is identical to the previously released version, USA36A4.2. However the designation of B4 in the software name will identify updated software in each device. CME America will contact all affected customers within 60 days to initiate the scheduling process for the remediation.
Your assistance is appreciated and necessary to prevent use and facilitate remediation of the recalled product. CME America can address any questions regarding the recalled product by calling the CME America recall line at 720-839-2391.
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
Gown, surgical - Product Code FYA
Cause
A single lot (11121171) of flyte toga peel-away x-large (catalog number 0408-830-100) was labeled with an incorrect expiration date of 2412-12-01. the correct expiration date should have read 2014-12-01.
Action
Stryker sent an Urgent Medical Device Recall Notification letter dated December 22, 2014, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and responding to the formal recall notification. Customers were instructed to do the following:
1. Immediately review this Recall Notification
2. Immediately check all stock areas and/or operating room storage and quarantine any affected product found.
3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how
many, if any, affected items are currently in their inventory. Complete and return the BRF even if they
do not have any affected product on hand.
Note: Your signature on the BRF indicates that you received and understand this Notification and
have followed the instructions in this Notification.
4. If customers further distributed this product, they were instructed to forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. Completed Business Reply Forms should be faxed to 866-521-2762.
Upon receipt of the Business Reply Form, Stryker will email a pre-paid shipper. This shipper can be used to return the recalled Flyte Toga(s) to Stryker.
Upon receipt of the recalled Flyte Toga(s), credit will be applied to the customer's account.
For questions regarding this recall customers were instructed to contact Stryker Instruments: Monday-Friday 8am-5pm (EST) at 269-389-2458.
For questions regarding this recall call 269-389-2458.
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.
Potential for leaking caused by insufficient bond between needleless device and female luer.
Action
Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them.
If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return.
Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential for leaking caused by insufficient bond between needleless device and female luer.
Action
Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them.
If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return.
Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential for leaking caused by insufficient bond between needleless device and female luer.
Action
Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them.
If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return.
Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential for leaking caused by insufficient bond between needleless device and female luer.
Action
Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them.
If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return.
Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential for leaking caused by insufficient bond between needleless device and female luer.
Action
Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them.
If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return.
Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential for leaking caused by insufficient bond between needleless device and female luer.
Action
Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them.
If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return.
Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential for leaking caused by insufficient bond between needleless device and female luer.
Action
Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them.
If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return.
Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential for leaking caused by insufficient bond between needleless device and female luer.
Action
Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them.
If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return.
Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential for leaking caused by insufficient bond between needleless device and female luer.
Action
Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them.
If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return.
Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential for leaking caused by insufficient bond between needleless device and female luer.
Action
Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them.
If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return.
Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential for leaking caused by insufficient bond between needleless device and female luer.
Action
Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them.
If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return.
Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.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.
Potential for leaking caused by insufficient bond between needleless device and female luer.
Action
Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them.
If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return.
Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.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
Monitor, bed patient - Product Code KMI
Cause
The transformers installed on carts used for richard wolf medical video systems may overheat causing smoke and black plastic material to leak from the cart chassis.
Action
Field Action Notice letters dated December 10, 2014 were sent to both direct accounts (customers). The letters instructed customers to: 1) Instruct the biomed to bypass the integrated power grid on the cart and not to use the electrical system on the affected carts until a qualified Omni Corporation service technician is able to inspect and repair the carts; and 2) Omni Corporation will schedule a qualified Omni field service technician, in conjunction with Richard Wolf and the customer's biomed unit, to visit and replace the transformer on the cart.
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.
Smiths medical has become aware of an issue with specific lots of 50ml cadd" medication cassette reservoirs ( cassette ). some cassettes may leak at the sealing area of the pump tube and medication bag. smiths medical has received no reports of
serious injury or death related to this issue.
Action
Smiths Medical sent an "Urgent Medical Device Recall" letter dated February 2, 2015, to all affected customers. The letter was addressed to Risk Safety Manger, Biomedical Professionals, Clinicians who oversee the use of CADD pumps, Distributors, and other users of these devices. The letter described the problem and the product involved in the recall. The letter also addressed the "Advice on Action to be Taken by the User", and "Transmission of this Urgent Recall Notice".
Customers were requested to complete and return the Confirmation Form by Fax to 1-800-237-8033 or be email to recall.response@smiths-medical. For issues with these products they can contact Smiths Medical's Global Complaint Department at 1-866-216-8806 or globalcompaints@smiths-medical.com. For questions on the information provided they can contact Customer Service Department at 1-800-258-5361.
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
Pump, infusion, insulin - Product Code LZG
Cause
The firm is informing customers of a software error that might result in an inaccurate display of the temp basal time and duration in carelink clinical reports with data uploaded from the minimed 620g or 640g insulin pump.
Action
Medtronic MiniMed Inc. sent an Urgent Medical Device Correction letter in December 2014 to all affected customers. The firm states in their letter that patients can continue to use their MiniMed 620G and 640G insulin pump systems, and that there is no risk to patients caused by this issue. The firm instructs that when reviewing the CareLink Pro 4.0 or CareLink Clinicial reports from the MiniMed 620G and 640G insulin pumps not to use the Temp Basal graphic for clinical consideration.
For questions regarding this recall call 818-567-4700.