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
Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde - Product Code OJZ
Causa
A change to the preparation for use section
was identified where 2.5cc was replaced with 2cc-3cc volume and was not approved.
Acción
The firm, Stryker Biotech, sent a "Medical Device Correction" letter on October 15, 2010 via return receipt letter to all customers. The letter contains labeling with the approved Preparation for Use Section of 2.5 cc volume and included the revised copy of the Package Insert. Additionally, the letter described the product, problem and actions to be taken. The customers were instructed to follow the new instructions provided and to keep the new instructions in mind when using the OP-1 Putty.
If you have any questions concerning this communication, please contact 508-416-5326 or Stryker Biotech's Pharmacovigilance department at PVG@stryker.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
One-Piece Scalpel - Product Code GDX
Causa
Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
Acción
On 9/3/2010, the firm notified consignees about the recall by facsimile letter. The letter instructed consignees to return scalpels for credit or replacement. The firm enlarged the scope of the recall on 11/15/2010. An additional 927 cases were recalled. This includes 11 additional lots. The firm sent out URGENT MEDICAL DEVICE RECALL letters dated 11/15/2010 to its direct accounts. The letter identified that affected product and the reason for the recall. The consignees were instructed to check their inventory, complete and return the attached Voluntary Recall Notification Confirmation Form, return the affected product to the manufacturer. Product return question should be directed towards Marc Pauze at 800-463-7146 ext 299 and regulatory questions should be directed towards Tish Anger at 800-463-7146 ext 342.
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
One-Piece Scalpel - Product Code GDX
Causa
Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
Acción
On 9/3/2010, the firm notified consignees about the recall by facsimile letter. The letter instructed consignees to return scalpels for credit or replacement. The firm enlarged the scope of the recall on 11/15/2010. An additional 927 cases were recalled. This includes 11 additional lots. The firm sent out URGENT MEDICAL DEVICE RECALL letters dated 11/15/2010 to its direct accounts. The letter identified that affected product and the reason for the recall. The consignees were instructed to check their inventory, complete and return the attached Voluntary Recall Notification Confirmation Form, return the affected product to the manufacturer. Product return question should be directed towards Marc Pauze at 800-463-7146 ext 299 and regulatory questions should be directed towards Tish Anger at 800-463-7146 ext 342.
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
One-Piece Scalpel - Product Code GDX
Causa
Scalpels labeled as sterile have the potential to be unsealed and therefore not sterile.
Acción
On 9/3/2010, the firm notified consignees about the recall by facsimile letter. The letter instructed consignees to return scalpels for credit or replacement. The firm enlarged the scope of the recall on 11/15/2010. An additional 927 cases were recalled. This includes 11 additional lots. The firm sent out URGENT MEDICAL DEVICE RECALL letters dated 11/15/2010 to its direct accounts. The letter identified that affected product and the reason for the recall. The consignees were instructed to check their inventory, complete and return the attached Voluntary Recall Notification Confirmation Form, return the affected product to the manufacturer. Product return question should be directed towards Marc Pauze at 800-463-7146 ext 299 and regulatory questions should be directed towards Tish Anger at 800-463-7146 ext 342.
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
Intra-Aortic Balloon and Control System - Product Code DSP
Causa
Superarrow flex iab catheter becomes stuck in the sheath, unable to move the iab catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.
Acción
Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.
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
Intra-Aortic Balloon and Control System - Product Code DSP
Causa
Superarrow flex iab catheter becomes stuck in the sheath, unable to move the iab catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.
Acción
Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.
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
Intra-Aortic Balloon and Control System - Product Code DSP
Causa
Superarrow flex iab catheter becomes stuck in the sheath, unable to move the iab catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.
Acción
Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.
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
Intra-Aortic Balloon and Control System - Product Code DSP
Causa
Superarrow flex iab catheter becomes stuck in the sheath, unable to move the iab catheter forward or backward, causing a delay in therapy, bleeding or arterial injury.
Acción
Arrow international initiated a voluntary recall on 12/21/10 by letter requesting users to discontinue use and return all unused 5800 Series IAB with SuperFlex Introducers to Arrow. This field action supercedes the Safety Alert IAB 'Stuck in Sheath' letter issued on 10/8/2010. Questions should be directed towards their local sales representative or the IABP support Line at 1-866-396-2111 or 1-617-389-6400.
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
Needle, hypodermic, single lumen - Product Code FMI
Causa
There is the possibility for certain lots of the bd vacutainer push button blood collection sets to have separation of the cannula from the hub.
Acción
BD Diagnostics sent "RECALL NOTIFICATION" separate letters October 1 and 5, 2010 and follow up letter dated October 8, 2010, as well as a letter dated December 1, 2010 to all distributors and customers commencing October 5, 2010 by federal express. The letters describe the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory for specific catalog and lot numbers, and return product from the lots following the instructions on the enclosed packing slip (BD will send replacement upon receipt of returned product). If you have any questions on returning and replacing product, please contact BD logistics at 1-866-380-0046.
If you have any further detail questions regarding this recall, please contact your BD Sales Consultant or BD Technical Services via email at www.BD.com/Vacutainer/Contact or via telephone at 1-800-631-0174.
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
Stent, carotid - Product Code NIM
Causa
The recall was initiated because abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. if the affected device is used it may result in acute stent deployment difficulties and subsequent intervention.
Acción
Abbott Vascular sent an URGENT DEVICE RECALL letter dated September 10, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken. The Sales Representatives were to personally visit each account to deliver the recall letter and assist in identifying and returning any
unused devices to Abbott Vascular. Also, Abbott Vascular Regulatory Compliance initiated contact with the Risk Management department at each account by phone to verify their mailing address and provide a courtesy copy of the recall letter.
The consignees were instructed to work with their local account representative to review their inventory, complete the Recall Effectiveness Check and return identified products to Abbott Vascular.
For questions regarding this recall call (951) 914-3324.
Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland.
Notas adicionales en la data
Advice regarding the use of the device. 3rd Party Publications
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
Stent, carotid - Product Code NIM
Causa
The recall was initiated because abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. if the affected device is used it may result in acute stent deployment difficulties and subsequent intervention.
Acción
Abbott Vascular sent an URGENT DEVICE RECALL letter dated September 10, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken. The Sales Representatives were to personally visit each account to deliver the recall letter and assist in identifying and returning any
unused devices to Abbott Vascular. Also, Abbott Vascular Regulatory Compliance initiated contact with the Risk Management department at each account by phone to verify their mailing address and provide a courtesy copy of the recall letter.
The consignees were instructed to work with their local account representative to review their inventory, complete the Recall Effectiveness Check and return identified products to Abbott Vascular.
For questions regarding this recall call (951) 914-3324.
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
Stent, carotid - Product Code NIM
Causa
The recall was initiated because abbott vascular has discovered through internal testing that the affected lots may not meet the firm's quality specifications for catheter shaft tensile strength. if the affected device is used it may result in acute stent deployment difficulties and subsequent intervention.
Acción
Abbott Vascular sent an URGENT DEVICE RECALL letter dated September 10, 2010, to all consignees. The letter identified the product, the problem, and the action to be taken. The Sales Representatives were to personally visit each account to deliver the recall letter and assist in identifying and returning any
unused devices to Abbott Vascular. Also, Abbott Vascular Regulatory Compliance initiated contact with the Risk Management department at each account by phone to verify their mailing address and provide a courtesy copy of the recall letter.
The consignees were instructed to work with their local account representative to review their inventory, complete the Recall Effectiveness Check and return identified products to Abbott Vascular.
For questions regarding this recall call (951) 914-3324.
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
Calibrator, dose, radionuclide - Product Code KPT
Causa
The spring arm on portable stand may have been over tightened during assembly, which may result in failure. if the spring arm fails, it will not balance the collimator weight, and the arm will drop to the lowest position.
Acción
Capintec issued an Alert letter to all customers identifying the affected device, informing them of the problem and what actions are to be taken by customers. Capintec will send a replacement arm for the system, which is to be installed by the customer using included instructions. The firm included a correction acknowledgement form to be completed and returned by the customer.
Customers can contact Capintec concerning this recall at 201 825-9500.
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
Multi-Analyte Controls - Product Code JJY
Causa
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Acción
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@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.
When connecting this cable to the mapping system, loss of body surface ecg signals may occur. this may result in inaccurate locations appearing for catheters displayed 3d on the carto monitor.
Acción
Biosense Webster issued an Urgent Field Safety Notice letter dated October 5, 2010. The letter identified the product, the problem,and the action to be taken by the customer. Customers were instructed to return the affected cable, accompanied by the attached Return Authorization form.
For questions regarding this recall call Biosense Webster at 909 839-8874.
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
Multi-Analyte Controls - Product Code JJY
Causa
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Acción
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@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.
Notas adicionales en la data
Multi-Analyte Controls - Product Code JJY
Causa
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Acción
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@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.
Notas adicionales en la data
Multi-Analyte Controls - Product Code JJY
Causa
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Acción
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@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.
Notas adicionales en la data
Multi-Analyte Controls - Product Code JJY
Causa
The recall was initiated because results were being reported as being out of range. firm is reassigning ranges for hdl cholesterol in product.
Acción
All customers were notified and given instructions, requirements, and expectations for their role in the Correction activities using the Notice of Correction with attached Returned Verification Forms which were supplied via fax, email or direct mail beginning on October 6, 2010.
Customers are to share the information provided in the Notice with their laboratory staff and retain the letter as part of their laboratory Quality System documentation. If any affected product had been further distributed to another laboratory, then a copy of the letter should be provided to them. Customers are to complete and fax the enclosed Verification Form within 10 days to confirm their receipt of the notice.
Consignees with questions about the information contained in the notification were instructed to contact:
Alere San Diego, Inc.
9975 Summers Ridge Road
San Diego, CA 92121
U.S.A.
Phone: 877 441 7440
FAX: 858 805 8457
E-mail: Response.ts@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.
Notas adicionales en la data
system, x-ray, mobile - Product Code IZL
Causa
Safety notice: door cable periodic maintenance schedule and cable wear for the o-arm¿¿ imaging system breakage of the door cable during opening and closing may occur and cause physical harm or delay of therapy.
Acción
Medtronic Navigation sent all consignees/customers an "Urgent Field Safety Notice" letter dated October 15, 2010. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review and follow the attached information that describes the process to properly detect and proactively manage cable wear; to ensure that the door is completely open when positioning the patient into or removing them from the gantry and when placing the O-ARM Imaging System Tube Drape (BI-900-00003) onto the unit, and report any visual or audible (cracking noise) wear of the cable to Medtronic Representative ASAP. Note: A Medtronic Representative will be contacting the customers within the coming weeks to schedule a time to inspect the current condition of the cable, explain and train the customers on the recommended workflow and inspection procedure and place a permanent label on their O-ARM Imaging System to reinforce these actions.
If you have any questions about this notification, please contact your local Medtronic Navigation representative or call our Technical Services Group at 800-595-9709 or 720-890-3200.
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.
Strains of acinetobacter radioresistens cross-react with both e. coli/p. aeruginosa pna fish and ek /p. aeruginosa pna fish to produce a false positive red signal.
Acción
AdvanDX sent an e-mail notification along with a PDF file to all customers on October 8, 2010, followed by written notification dated October 6, 2010. The letter identified the product, the problem, and the action the customers should take. Customers were instructed to replace the package insert(s) included with any kits in their inventory with the enclosed package insert(s). Customers were also instructed to fill out the enclosed Acknowledgement of Receipt Form and return it to AdvanDx to confirm that they received the new package insert.
For questions regarding this recall contact AdvanDx Technical Support at
1-888-376-0009.
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.
Strains of acinetobacter radioresistens cross-react with both e. coli/p. aeruginosa pna fish and ek/p. aeruginosa pna fish to produce a false positive red signal.
Acción
AdvanDx issued a customer letter dated October 6, 2010 with a PDF file of a new package insert and an acknowledgement form to fill out and return to AdvanDx. Customers were instructed to replace the package insert in any existing inventory with the enclosed package insert.
Customers can contact AdvanDx technical support about this action at 1-866-376-0009.
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
Activated whole blood clotting time - Product Code JBP
Causa
Certain lots of i-stat celite act and kaolin act cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.
Acción
Abbott Point of Care, Inc. sent an URGENT RECALL NOTICE dated September 2010 on October 6, 2010 by Federal Express to all US customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of cartridges from the identified lots. If customers did not currently have replacement cartridges then they should continue to use the cartridge lot until their facility receives replacement material.
Upon receipt of replacement material, customers were to discontinue use of and return the affected cartridges and switch to the replacement material. All unused cartridges will be credited and will be returned.
If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.
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
Activated whole blood clotting time - Product Code JBP
Causa
Certain lots of i-stat celite act and kaolin act cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.
Acción
Abbott Point of Care, Inc. sent an URGENT RECALL NOTICE dated September 2010 on October 6, 2010 by Federal Express to all US customers. The letter identified the product, the problem, and the action to be taken by the customer.
Customers were instructed to discontinue use of cartridges from the identified lots. If customers did not currently have replacement cartridges then they should continue to use the cartridge lot until their facility receives replacement material.
Upon receipt of replacement material, customers were to discontinue use of and return the affected cartridges and switch to the replacement material. All unused cartridges will be credited and will be returned.
If you have any questions regarding this information, please contact Abbott Point of Care Technical Support at 800-366-8020, Option 1 or your Abbott Point of Care representative.