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.
Boston scientific is initiating an important field correction related to wallstent", wallstent" rp, and wallgraft¿ tracheobronchial endoprosthesis products. this letter is intended to clarify and re-emphasize that u.S. wallstent", wallstent" rp, and wallgraft¿ tracheobronchial endoprosthesis stents are not currently cleared by the fda for use in benign tracheobronchial strictures.
Acción
The firm, Boston Scientific, sent an "Urgent Medical Device Field Correction" letter dated May 25, 2011 to its customers. The letter described the product, the problem and actions to be taken. The letter states that no product is being recalled and asks consignees not to return the product. The customers were instructed to read the enclosed information and post it in a way to ensure it is easily accessible to all users of this device; complete and return the Reply Verification Tracking Form via fax to: CV Field Action Center, 1-866-213-1806, and if they are a distributors to forward this notification to their customers.
If you have any questions or would like assistance with this field correction, please contact your local Sales Representative and/or call 763-494-1133.
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.
Boston scientific is initiating an important field correction related to wallstent", wallstent" rp, and wallgraft¿ tracheobronchial endoprosthesis products. this letter is intended to clarify and re-emphasize that u.S. wallstent", wallstent" rp, and wallgraft¿ tracheobronchial endoprosthesis stents are not currently cleared by the fda for use in benign tracheobronchial strictures.
Acción
The firm, Boston Scientific, sent an "Urgent Medical Device Field Correction" letter dated May 25, 2011 to its customers. The letter described the product, the problem and actions to be taken. The letter states that no product is being recalled and asks consignees not to return the product. The customers were instructed to read the enclosed information and post it in a way to ensure it is easily accessible to all users of this device; complete and return the Reply Verification Tracking Form via fax to: CV Field Action Center, 1-866-213-1806, and if they are a distributors to forward this notification to their customers.
If you have any questions or would like assistance with this field correction, please contact your local Sales Representative and/or call 763-494-1133.
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.
Notas adicionales en la data
Light, operating, dental - Product Code EAZ
Causa
Lens heat shield (birdcage) of the luxstar dental light could fall and injure a patient.
Acción
Dental Equipment, LLC sent an "URGENT MEDICAL DEVICE RECALL" notification letter via USPS 1st class to US consignees and via Federal Express or Fax to foreign consignees on June 24, 2011. The letter informed customers about the product, problem and tether upgrade corrective action. A Field Correction Acknowledgement Form and the Field Correction Completion Form was attached for customers to complete and return via the fax number 503-537-3617. The letter states that customers are to review their records in order to identify where the affected devices are located and which are still in service. Customers can call the Customer Service at 800-304-5332 and order the self-install Upgrade Kits with the Part Number 30792 at no charge.
Customers are instructed to complete the Rework Correction Form once all of the lights have been updated and fax or mail to Marcus, attention Bonnie Dundas, at (503) 537-3617.
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.
Notas adicionales en la data
Screw, oral - Product Code KBW
Causa
Biomet microfixation, jacksonville, fl is recalling part number 01-6577, 2.0x7 mm fossa x-drive screws, 5 pack, lot # 233270. this product is being recalled due to the possibility that the pack may have contained another part, 01-6581 2.0x11 mm fossa x-drive screws, 5 pack.
Acción
Biomet Microfixation, Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 25, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers.
The letter instructs customers to complete and return an Inventory Reconciliation form via fax to 904-741-9425. The form requests that customers indicate whether they want to keep the product or return for credit.
Customers can contact the Customer Relations Specialist at 1-800-874-7711 or 904-741-4400 ext. 468 for questions regarding this 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.
Notas adicionales en la data
Digital Image Storage System, Radiological - Product Code LMB
Causa
A potential safety issue exists for data transfer between lantis ois system (containing primeview or primeview data gateway) and the sequencer v&r; system via a third party interface is used.
Acción
Siemens sent an "Update Instructions/Customer Safety Advisory Notice" to all affected users, beginning June 30, 2011.
The letter includes description of the product and problem and provides updated instructions to ensure data is stored in the system.
If you have questions contact Siemens at (925) 602-8157.
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.
Alere is initiating a voluntary recall on the listed lots of multi-drug 9 panel integrated cup manufactured by alere for sole use by calloway labs due to a mistake that occurred while processing the order, these products were incorrectly
labeled as clia waived, when in fact the devices are classified as moderately complex. therefore these devices are misbranded.
Acción
Alere San Diego sent an "Urgent Medical Device Recall" letter dated June 9, 2011 to all affected customers.
The letter included: products affected, reason for recall and instructed them to return all affected product. An acknowledgement form was also included for the customer to return to Alere.
For questions contact Technical Services at 888.246.7483, option 2 or by e-mail at InnovaconComplaints@alere.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.
The xio software currently prompts for entry of ct to ed data for a studyset. no indication is given that the electron density data should only be used for photon and electron calculations and either relative stopping power or mass density should be used for proton calculations (depending on the algorithm).
Acción
The firm, Eletka, Inc., issued an "Important Safety Notice" dated May 18, 2011 via mail to all affected sites. The notice explains the issue and identifies a work around to the problem until the new release is available. The customers were instructed to complete and return the enclosed "Confirmation of Receipt" form via FAX to 314-993-1175, attn: QA; e-mail or mail: CMS Software, Attn: QA, 13723 Riverport Drive, Suite 100, Maryland Heights, MO 63043.
The notice states that "this problem has existed since XiO Release 2.4.0 and has been resolved in XiO Release 4.63.0 by adding warning messages and explanations to the XiO On-Line Help. Your site will be notified when this release is available."
If you have any question, call 314-993-0003, 800-878-4267 or 408-830-8023.
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.
Syringes packaged and labeled as the illumena 150ml linden luer syringe with handi-fil straw, product 900103, contained the illumena150ml syringe with handi-fil straw, product 900101.
Acción
COVIDIEN sent an Urgent Device Recall letter dated May 20, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to use the attached business response form and report the quantity of lot number 0253304 currently in their stock. If the customer did not have any of the affected lot they were to indicate by checking the appropriate box on the form. When completed, customers were asked to fax to (314) 654-8206 or email to productmonitoringhazelwood@covidien.com. All product from lot number 0253304 was to be returned to Covidien. Once the business notification form is received a Return Goods Authorization for the quantity of product reported will be sent to the customer. Customers would receive credit for all return product from affected lot.
For any questions regarding this recall customers were asked to contact the Product Monitoring department at 800-778-7898. For questions about credit for the product, call Customer Service at 888-744-1414, menu option 1, and then menu option 2.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended.
Acción
Asante sent urgent medical device recall notifications letters to distributors and customers on November 19, 2013 by US mail, return receipt requested.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, silk - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, synthetic, polyamide - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
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.
Notas adicionales en la data
Suture, nonabsorbable, synthetic, polyethylene - Product Code GAP
Causa
Potential for the sterile barrier to be breached compromising the sterility of the product.
Acción
Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product.
Customers were instructed to contact Covidien Customer Service at SDFeedback@Covidien.com or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product.
Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.