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.
Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087.
For questions regarding this recall call 508-270-2285.
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.
Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087.
For questions regarding this recall call 508-270-2285.
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.
Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087.
For questions regarding this recall call 508-270-2285.
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.
Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087.
For questions regarding this recall call 508-270-2285.
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.
Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087.
For questions regarding this recall call 508-270-2285.
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.
Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087.
For questions regarding this recall call 508-270-2285.
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.
Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087.
For questions regarding this recall call 508-270-2285.
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.
Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087.
For questions regarding this recall call 508-270-2285.
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.
Genzyme sent a Medical Device Recall Notification letter dated June 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were avised to immediately discontinue use of all lots of LeGoo Endovascular Occlusion Gel and return all LeGoo and return product with the shipping label and packing slip enclosed. syringes.Complete the reply card via fax (414) 459-8791. Customer with questions were instructed to call GENCO at 877-674-2087.
For questions regarding this recall call 508-270-2285.
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
Filter, blood, cardiopulmonary bypass, arterial line - Product Code DTM
Causa
Medtronic is recalling 148 affinity pediatric arterial filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted particulate or gaseous emboli to pass through the filter and the outlet of the device, which could result in serious injury to a pediatric patient including neurological damage, or potential patient death.
Acción
Customer communication was initiated verbally on June 14, 2013, to the 4 affected customers to quarantine any un-used units. An Urgent Medical Device Recall letter, dated June 26, 2013. was mailed to customers on June 28, 2013. The Urgent Medical Device letter referenced that the letter is in follow-up to the previous phone call. It identified the affected product, stated the issue with the 2 affected lot numbers and health risks, and asked that the affected devices be quarantined for return to Medtronic.
If you have any questions please contact your Medtronic Sales representative or Lifeline Technical Services at 1-877-526-7890. 1-763-526-7890.
Update: Customer communication to the newly identified customer was initiated verbally on August 20,2013, with the customer letter delivery beginning AUG 27, 2013. A Medtronic representative is available to facilitate the return of affected product.
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
Susceptibility test discs, antimicrobial - Product Code JTN
Causa
Boxes labeled as cip5 may contain cartridges of amp5.
Acción
Thermo Fisher sent a Field Safety Notice dated November 13, 2012, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to check stocks of the affected product if necessary and contact Customer Service or their local Oxoid supplier who will issue a replacement. The notice should be passed on to all who need to be aware within their organization. Customers were also instructed to discard any product labeled as AMP5. For questions, customers were instructed to call +44 (0)1256 841144.discard any product labeled AMP5.
For questions regarding this recall call 913-895-4185.
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 were produced using the wrong color material, resulting in the devices
being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).
Acción
Smith & Nephew sent an Urgent Recall Notification letter dated July 8, 2013 to all affected customers. Surgeons were notified by letter beginning on July 16, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, locate unused devices, quarantine immediately, and return affected product to the address provided in the notification. For questions email to FieldActions@smith-nephew.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.
Notas adicionales en la data
Hemodialysis system for home use - Product Code ONW
Causa
Updated instructions for use: bloodline connections not tightened per instructions in the operator's manual may disconnect and lead to blood loss.
Acción
Fresenius issued a Field Notification Letter dated 8/29/13 to Patient Clinics/ associated at home patients and provides additional detail instructions to ensure the connection to the transducer protector bloodline female luer interface is secure.
This field advisory notice sent by Certified Mail, Return Receipt Requested. Accounts requested to return both the receipt and the completed reply form (enclosed) to confirm receipt of the notice.
If you have any questions regarding this field advisory, please contact FMCNA Customer Service Team at 1-800-323-5188. Customer Service will be available Monday-Friday 7am-6pm CST.
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.
Integra lifesciences corporation has determined that there is a possibility that some lots of licox cmp brain tissue oxygen and temperature catheter kits contain a hex wrench that does not loosen the set screw on the drill bit.
Acción
Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile.
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.
Integra lifesciences corporation has determined that there is a possibility that some lots of licox cmp brain tissue oxygen and temperature catheter kits contain a hex wrench that does not loosen the set screw on the drill bit.
Acción
Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile.
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.
Integra lifesciences corporation has determined that there is a possibility that some lots of licox cmp brain tissue oxygen and temperature catheter kits contain a hex wrench that does not loosen the set screw on the drill bit.
Acción
Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile.
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.
Integra lifesciences corporation has determined that there is a possibility that some lots of licox cmp brain tissue oxygen and temperature catheter kits contain a hex wrench that does not loosen the set screw on the drill bit.
Acción
Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile.
The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Switzerland.
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.
Medtronic navigation, inc. has initiated a field correction to their framelink software version 5.4 which can be used on medtronic navigation stealthstation 57 and i7 systems or a medtronic planning station due to the potential of discrepancy between the exam image and the displayed measurement or overlay under certain conditions of use.
Acción
A Field Safety Notice was sent on 7/15/13 to users informing them that the Framelink software version 5.4 has been revised to correct the software anomalies described in this letter. A new version will be installed on their system(s) by a Medtronic Navigation representative. Until the software upgrade has been installed on their system, do not use high resolution examinations (greater than 256 x 256). If users are not sure of the exam resolution being used, firm recommend contacting the hospital imaging department or local Medtronic Navigation representative for assistance. Medtronic representatives will visit all identified hospitals and upgrade all systems to version 5.4.1. This will account for all consignees.
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.
Edwards lifesciences is recalling certain lots of the
endoreturn arterial cannula that were built with an incorrect component. this component can create a
performance problem with the intraclude intraaortic occlusion device.
Acción
Edwards sent an Urgent Field Safety Notice letter dated July 16, 2013 via Fed-Ex. The letter identified the affected product, problem and action to be taken. The letter included a Customer Acknowledgement Form to be completed and faxed to 800-422-9329 Attn: Recall Coordinator. If the customer does not send back the acknowledgement form, two additional contacts are made to notify the customer and request return of affected product. This is tracked by Edwards customer service and reported each week. Customer were requested to assess their inventory to assure that all affected product is identified and returned. Returned products will be destroyed. For questions call Edwards Customer Service at 800-424-3278.
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
Susceptibility test cards, antimicrobial - Product Code LTW
Causa
A product issue has been identified for customers using software version 6.01 and are interfaced with a laboratory information system (lis). during the update of software from version 5.Xx to 6.01, the bid-directional computer interface (bci) antibiotic codes are not updated properly for cefovecin, prulifloxacin and ceftaroline. for the referenced antibiotics, the firm code in the reference table.
Acción
The firm, bioMerieux, sent an "Urgent Product Correction Notice" letter dated June 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure the Urgent Product Correction Notice and the Instructions for modifying BCI Translation Codes are distributed to all appropriate personnel in your organization; follow the instructions in the attached file (Instructions for modifying BCI Translation Codes) to resolve the discrepancy associated with Cefovecin, Prulifloxacin and Ceftaroline in the translation table and complete and return the Attachment A: Acknowledgement Form via Fax to: Attn: RA North American ComOps at (919)287-2542.
If you require additional assistance or have any questions, please contact your local bioMerieux Clinical Customer Service organization at (800) 682-2666 or Industrial Customer Service organization at (800) 634-7656.
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
Susceptibility test cards, antimicrobial - Product Code LTW
Causa
A product issue has been identified for customers using software version 6.01 and are interfaced with a laboratory information system (lis). during the update of software from version 5.Xx to 6.01, the bid-directional computer interface (bci) antibiotic codes are not updated properly for cefovecin, prulifloxacin and ceftaroline. for the referenced antibiotics, the firm code in the reference table.
Acción
The firm, bioMerieux, sent an "Urgent Product Correction Notice" letter dated June 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure the Urgent Product Correction Notice and the Instructions for modifying BCI Translation Codes are distributed to all appropriate personnel in your organization; follow the instructions in the attached file (Instructions for modifying BCI Translation Codes) to resolve the discrepancy associated with Cefovecin, Prulifloxacin and Ceftaroline in the translation table and complete and return the Attachment A: Acknowledgement Form via Fax to: Attn: RA North American ComOps at (919)287-2542.
If you require additional assistance or have any questions, please contact your local bioMerieux Clinical Customer Service organization at (800) 682-2666 or Industrial Customer Service organization at (800) 634-7656.
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
Susceptibility test cards, antimicrobial - Product Code LTW
Causa
A product issue has been identified for customers using software version 6.01 and are interfaced with a laboratory information system (lis). during the update of software from version 5.Xx to 6.01, the bid-directional computer interface (bci) antibiotic codes are not updated properly for cefovecin, prulifloxacin and ceftaroline. for the referenced antibiotics, the firm code in the reference table.
Acción
The firm, bioMerieux, sent an "Urgent Product Correction Notice" letter dated June 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure the Urgent Product Correction Notice and the Instructions for modifying BCI Translation Codes are distributed to all appropriate personnel in your organization; follow the instructions in the attached file (Instructions for modifying BCI Translation Codes) to resolve the discrepancy associated with Cefovecin, Prulifloxacin and Ceftaroline in the translation table and complete and return the Attachment A: Acknowledgement Form via Fax to: Attn: RA North American ComOps at (919)287-2542.
If you require additional assistance or have any questions, please contact your local bioMerieux Clinical Customer Service organization at (800) 682-2666 or Industrial Customer Service organization at (800) 634-7656.
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
Susceptibility test cards, antimicrobial - Product Code LTW
Causa
A product issue has been identified for customers using software version 6.01 and are interfaced with a laboratory information system (lis). during the update of software from version 5.Xx to 6.01, the bid-directional computer interface (bci) antibiotic codes are not updated properly for cefovecin, prulifloxacin and ceftaroline. for the referenced antibiotics, the firm code in the reference table.
Acción
The firm, bioMerieux, sent an "Urgent Product Correction Notice" letter dated June 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure the Urgent Product Correction Notice and the Instructions for modifying BCI Translation Codes are distributed to all appropriate personnel in your organization; follow the instructions in the attached file (Instructions for modifying BCI Translation Codes) to resolve the discrepancy associated with Cefovecin, Prulifloxacin and Ceftaroline in the translation table and complete and return the Attachment A: Acknowledgement Form via Fax to: Attn: RA North American ComOps at (919)287-2542.
If you require additional assistance or have any questions, please contact your local bioMerieux Clinical Customer Service organization at (800) 682-2666 or Industrial Customer Service organization at (800) 634-7656.
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
Susceptibility test cards, antimicrobial - Product Code LTW
Causa
A product issue has been identified for customers using software version 6.01 and are interfaced with a laboratory information system (lis). during the update of software from version 5.Xx to 6.01, the bid-directional computer interface (bci) antibiotic codes are not updated properly for cefovecin, prulifloxacin and ceftaroline. for the referenced antibiotics, the firm code in the reference table.
Acción
The firm, bioMerieux, sent an "Urgent Product Correction Notice" letter dated June 14, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to ensure the Urgent Product Correction Notice and the Instructions for modifying BCI Translation Codes are distributed to all appropriate personnel in your organization; follow the instructions in the attached file (Instructions for modifying BCI Translation Codes) to resolve the discrepancy associated with Cefovecin, Prulifloxacin and Ceftaroline in the translation table and complete and return the Attachment A: Acknowledgement Form via Fax to: Attn: RA North American ComOps at (919)287-2542.
If you require additional assistance or have any questions, please contact your local bioMerieux Clinical Customer Service organization at (800) 682-2666 or Industrial Customer Service organization at (800) 634-7656.