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.
Abbott vascular is initiating a recall on the viatrac 14 plus 5.0x15 mm peripheral dilation catheter due to a mistake in labeling/packaging.
Action
Abbott Vascular issued an "Urgent Device Recall" notification dated May 7, 2009. Consignees were informed of the affected product and instructed to work with local sales representatives in identifying any unused devices and arrange for return to the firm.
For further information, contact Abbott Vascular Customer Service at 1-800-227-9902.
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
Stent, carotid - Product Code NIM
Cause
Abbott vascular is initiating a recall on the xact carotid stent system because the product was distributed prior to approval of a pma supplement for a manufacturing line move between sites. there are no product quality issues associated with this action.
Action
Notification was sent out to all consignees about the product recall. Representatives from Abbott Vascular personally visited consignees and removed product from site.
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
Stent, carotid - Product Code NIM
Cause
Abbott vascular is initiating a recall on the xact carotid stent system because the product was distributed prior to approval of a pma supplement for a manufacturing line move between sites. there are no product quality issues associated with this action.
Action
Notification was sent out to all consignees about the product recall. Representatives from Abbott Vascular personally visited consignees and removed product from site.
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
Resin, root canal filling - Product Code KIF
Cause
Sybron dental specialties is initiating a recall on the sealapex xpress due to the presence of crystals in the catalyst. this crystallization may affect proper canal filling by preventing gutta percha points from reaching the bottom of the root canal which may lead to an inadequate seal.
Action
SybronEndo initiated an "Urgent Medical Device Recall" notification dated February 19 , 2009. Consignees were instructed to complete a "return form" and return any affected product in their inventory to the firm. Any product returned will be replaced at no charge.
For further information, contact SybronEndo Customer Care at 1-800-346-3636.
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.
Sharn anesthesia inc., tampa, fl received reports of leaking containers following use of their sharn anesthesia microblast nasal and pediatric laryngeal atomizer device.
Action
Recalling firm is contacting all direct accounts (distributors & user facilities) by telephone and letter. They request completion and return of the of the Return Goods Form and of any affected product by UPS using the firm's account number.
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.
Unimed surgical products, inc., largo, fl initiated a voluntary recall of the extended ptfe coated blade electrosurgical electrodes, product number es0014, due to concerns regarding product sterility for lot #042209-03.
Action
Unimed Surgical Products, Inc. issued a Medical Device Removal letter dated August 28, 2009. The customer, Medline Industries, Inc., was instructed to quarantine any undistributed product and to notify its customers of the recall.
For further information, contact Unimed Surgical Products, Inc. at 1-727-546-1900 or 1-800-886-1225.
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.
Sharn anesthesia inc., tampa, fl received reports of leaking containers following use of their sharn anesthesia microblast nasal and pediatric laryngeal atomizer device.
Action
Recalling firm is contacting all direct accounts (distributors & user facilities) by telephone and letter. They request completion and return of the of the Return Goods Form and of any affected product by UPS using the firm's account number.
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.
Sharn anesthesia inc., tampa, fl received reports of leaking containers following use of their sharn anesthesia microblast nasal and pediatric laryngeal atomizer device.
Action
Recalling firm is contacting all direct accounts (distributors & user facilities) by telephone and letter. They request completion and return of the of the Return Goods Form and of any affected product by UPS using the firm's account number.
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
Emission computed tomography system - Product Code JAK
Cause
Upper patient pallet component of the recalling firm's gemini pet/ct system may be thinner than normally required, which may reduce the product's load bearing capacity, resulting in cracking under less than the designed full-load weight.
Action
The firm notified customers with an "URGENT - Field Safety Notice" which was sent to the user/customers via FedEx on 1/26/2009. The letter informs customers of this potential safety hazard; the actions to be taken by the user/customer in order to mitigate risk to patients while undergoing scans; and the actions planned by Philips Medical's Service Engineers in order to correct the problem. The notification refers the user/customers to the applicable sections of their Systems Operations and Systems Information Manuals for a review on procedures for safely loading; unloading; and monitoring patients before, during, and after scanning studies. The notice goes on to inform the customers that replacement parts for the upper patient pallet(s) are on order and that a Philips Healthcare Field Service Engineer will be visiting each customer site within two (2) months in order to replace each affected pallet. Lastly, the notification provides a toll-free telephone number and instructions which the customer can use to contact a local Philips representative if additional information, or assistance is required. The firm's Customer Care Center contact is 1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology.
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
Emission computed tomography system - Product Code JAK
Cause
Upper patient pallet component of the recalling firm's gemini pet/ct system may be thinner than normally required which may reduce the product's load bearing capacity, resulting in cracking under less than the designed full-load weight.
Action
The firm notified customers with an "URGENT - Field Safety Notice" which was sent to the user/customers via FedEx on 1/26/2009. The letter informs customers of this potential safety hazard; the actions to be taken by the user/customer in order to mitigate risk to patients while undergoing scans; and the actions planned by Philips Medical's Service Engineers in order to correct the problem. The notification refers the user/customers to the applicable sections of their Systems Operations and Systems Information Manuals for a review on procedures for safely loading; unloading; and monitoring patients before, during, and after scanning studies. The notice goes on to inform the customers that replacement parts for the upper patient pallet(s) are on order and that a Philips Healthcare Field Service Engineer will be visiting each customer site within two (2) months in order to replace each affected pallet. Lastly, the notification provides a toll-free telephone number and instructions which the customer can use to contact a local Philips representative if additional information, or assistance is required. The firm's Customer Care Center contact is 1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology.
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
Disposable Contact Lens - Product Code MVN
Cause
Thirty-eight lots of ocufilcon d 55% 1-day toric contact lens with a modified packaging solution sold under the brand name clearsight 1-day toric were inadvertently shipped into the us market prior to complete evaluation of the 510(k) by the fda.
Action
Urgent: Medical Device Recall - Contact Lens letters, dated 8/28/09, Response Forms, along with reorder forms and postage paid return labels were sent to the consignees via first class mail with instructions for returning the affected product. Customers are to examine their inventory and customer records to determine if they have any of the affected product. The affected products are to be returned and CooperVision will reimburse for all postage associated with the return and replace the lenses free of charge. Questions should be directed to Bonnie Tsymbal at (800) 341-2020 ext. 3210.
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.
A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.
Action
On September 28, 2009 Philips issued a nationwide press release. On October 1, 2009 the firm issued notification letters to consignees arranging for the return and replacement of the affected units. The firm also set up a page on their website with a serial number look-up tool.
For further information or support concerning this issue, customers are asked to contact Philips at 1.800.263.3342 or visit www.philips.com/FR2PlusAction for the serial number look-up list, answers to frequently asked questions, directions for the battery insertion test, and the replacement AED selection form.
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
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Cause
There have been reports of clinically significant fluid imbalance when a certain level of fluid imbalance is detected the aquarius will trigger an alarm, however, users are able to override this alarm and continue therapy. it is possible to remove too much fluid from or replace too much fluid to the patient. in extreme cases, this may result in serious injuries or death.
Action
Edwards is continuing a field corrective action related to the possibility of fluid imbalance when using the Aquarius. In order to mitigate some of the risk associated with this problem, Edwards sent notifications to consignees advising of mitigation steps. Consignees were provided: a description of the affected product, problem, and potential hazard; advice on action to be taken; and revised device labeling. Additionally, consignees were notified of a planned software upgrade to prevent users from bypassing the fluid balance alarm more than five times in a 20-minute period. Although Edwards does not believe there is a need to stop using the Aquarius system at this time, clinicians should weigh the risks/benefits to the patients before continuing the use of the device Edwards first provided some of this information to consignees in a Field Safety Notice on March 16, 2009. On January 11, 2010, Edwards provided an Urgent Product Recall letter to consignees which updated and expanded the earlier communication. The FDA classified this as a Class I recall.
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 products may give false positive results with some non-staphylococcus aureus strains.
Action
Thermo Fischer Scientific, Remel Inc. issued letters dated July 20, 2009 via regular mail explaining the reason for recall, risks involved, and requested they discard all remaining product. A Product Inventory Checklist was enclosed to report the amount of product their customer discarded. A second letter dated October 19, 2009 was issued via certified mail.
For further information, contact Thermo Fischer Scientific, Remel Inc. at 1-800-255-6730, Extension 3304185.
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 products may give false positive results with some non-staphylococcus aureus strains.
Action
Thermo Fischer Scientific, Remel Inc. issued letters dated July 20, 2009 via regular mail explaining the reason for recall, risks involved, and requested they discard all remaining product. A Product Inventory Checklist was enclosed to report the amount of product their customer discarded. A second letter dated October 19, 2009 was issued via certified mail.
For further information, contact Thermo Fischer Scientific, Remel Inc. at 1-800-255-6730, Extension 3304185.
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, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
Cause
The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.
Action
Terumo Cardiovascular Systems Corporation notified consignees of an "Urgent Medical Device Correction" by letter on July 06, 2009. The letter was addressed to hospital Perfusion, Cardiovascular Surgery, and Operating Room departments and contained specific measures to be taken to ensure proper use of the affected device. The firm recommended that users continue to use the devices and follow the corrective measures enclosed with the notification. Consignees were requested to route the notification to all users and confirm receipt of the notification by returning a customer response form.
For further information, contact Terumo CVS Customer Service at 1-800-521-2818.
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, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
Cause
The tubing- to- pump connection in a medical device used in surgical procedures may disengage resulting in blood loss.
Action
Terumo Cardiovascular Systems Corporation notified consignees of an "Urgent Medical Device Correction" by letter on July 06, 2009. The letter was addressed to hospital Perfusion, Cardiovascular Surgery, and Operating Room departments and contained specific measures to be taken to ensure proper use of the affected device. The firm recommended that users continue to use the devices and follow the corrective measures enclosed with the notification. Consignees were requested to route the notification to all users and confirm receipt of the notification by returning a customer response form.
For further information, contact Terumo CVS Customer Service at 1-800-521-2818.
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
Transfer Aid - Product Code IKX
Cause
Safety chair used in shower/bath may not meet specifications for weight load.
Action
The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be replaced.
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
Transfer Aid - Product Code IKX
Cause
Safety chair used in shower/bath may not meet specifications for weight load.
Action
The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be replaced.
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
Transfer Aid - Product Code IKX
Cause
Safety chair used in shower/bath may not meet specifications for weight load.
Action
The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be replaced.
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
Transfer Aid - Product Code IKX
Cause
Safety chair used in shower/bath may not meet specifications for weight load.
Action
The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be replaced.
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
Transfer Aid - Product Code IKX
Cause
Safety chair used in shower/bath may not meet specifications for weight load.
Action
The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be replaced.
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
Transfer Aid - Product Code IKX
Cause
Safety chair used in shower/bath may not meet specifications for weight load.
Action
The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be replaced.
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
Bone Densitometer - Product Code KGI
Cause
Failure to properly pre-indicate the technique factors to be used during a patient scan.
Action
An Important Electronic Product Radiation Warning letter will be sent to customers. The letter will discuss the defect description and related hazards, the affected product details, safety instructions, and product correction. Customers are to contact their local GE Healthcare service representative with questions.
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.
Biomet microfixation, inc. is recalling their onpoint tmj kit (part numbers 24-3050, 24-3055) and arthrosimplicity tmj arthocentesis kit (part numbers 922070, 922090, 922075). these two kits contain a bd sterile disposable 60 ml luer-lok syringe, part number 309653 which is under recall by becton dickinson (recall number z-2347-2008). becton dickinson has determined that unit package seal integ.
Action
Consignees were notified by a combination of telephone, fax, e-mail and certified mail.
Questions related to this notice should be directed to Christy Cain at 1-800-874-7711.