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
Catheter, biliary, diagnostic - Product Code FGE
Causa
Boston scientific is initiating this medical device field correction of the expel" apd and apdl
drainage catheters. to date, boston scientific has received one complaint for device fragmentation
after an expel" apd catheter was implanted in the biliary system. the most serious foreseeable patient
risk for this issue is additional intervention for fragment retrieval using minimally invasive meth.
Acción
Boston Scientific sent an "Urgent Medical Device Correction" letter dated February 25, 2015, to all affected customers. The letter described the problem and the product involved in the recall.
The letter informed customers not to use the Expel APD and APDL Drainage catheters for bile drainage and to complete and return the Customer Acknowledgement Form. The letter also noted that the devices are not being retrieved and they are not required to return them to Boston Scientific. For further questions please call (763) 494-7971.
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
Probe, lachrymal - Product Code HNL
Causa
Expiration date incorrectly printed in manufacturing date field on both pouch and carton labels.
Acción
The consignees were notified by letter on 3/2/2015. The recalling firm requested the consignees to return the recalled product for a replacement device.
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
Introducer, catheter - Product Code DYB
Causa
Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the steerable sheath, outside of the patients bodies.
Acción
The firm, Medtronic, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 2015 to its consignees/customers. Medtronic representatives, beginning Monday, Feb 23, 2015 hand delivered the letter to US consignees/customers.. The letter was addressed to Physician, Risk Manager and Health Care Professional. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately quarantine all unused product; return all affected product to Medtronic; contact Customer Service at 1-800-848-9300 to initiate product return and to complete and return the Customer Confirmation Certificate to via email to: RS.CFQFCA@Medtronic.com or fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. In additions, consignees/customers should share this notification with others in your organization.
Your Medtronic field representative may assist the customers with identifying suitable replacement product.
If you have any questions, contact Customer Service at 1-800-848-9300.
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
The outer carton label and package insert for the recalled product incorrectly lists streptococcus pneumoniae as an organism for intended use.
Acción
Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following:
" Please confirm this letter has been distributed and reviewed by all appropriate personnel within your
organization.
" For the referenced test kits (VITEK¿ 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in
the Package Insert antibiotic table to confirm which organisms can be tested.
" Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae.
" Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms.
" Please store this letter with your bioM¿rieux instrument documentation.
Please complete the attached Acknowledgement Form and return it to bioM¿rieux, Inc.
Customers with questions were instructed to contact their local BioMerieux representative.
For questions regarding this recall call 314-731-8526.
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
The outer carton label and package insert for the recalled product incorrectly lists streptococcus pneumoniae as an organism for intended use.
Acción
Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following:
" Please confirm this letter has been distributed and reviewed by all appropriate personnel within your
organization.
" For the referenced test kits (VITEK¿ 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in
the Package Insert antibiotic table to confirm which organisms can be tested.
" Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae.
" Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms.
" Please store this letter with your bioM¿rieux instrument documentation.
Please complete the attached Acknowledgement Form and return it to bioM¿rieux, Inc.
Customers with questions were instructed to contact their local BioMerieux representative.
For questions regarding this recall call 314-731-8526.
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
The outer carton label and package insert for the recalled product incorrectly lists streptococcus pneumoniae as an organism for intended use.
Acción
Biomerieux, Incs sent an Urgent Product Correction Notice on February 25, 2015, to all affected customers. The letter identified the product, the problem, and the actions to be taken by the customer. Customers were instructed to do the following:
" Please confirm this letter has been distributed and reviewed by all appropriate personnel within your
organization.
" For the referenced test kits (VITEK¿ 2 ASTP635, ASTP640 or ASTP641), review the claimed organisms in
the Package Insert antibiotic table to confirm which organisms can be tested.
" Refrain from using the referenced test kits to determine the susceptibility of Streptococcus pneumoniae.
" Reference your Laboratory Standard Operating Procedures to identify card type used for specific organisms.
" Please store this letter with your bioM¿rieux instrument documentation.
Please complete the attached Acknowledgement Form and return it to bioM¿rieux, Inc.
Customers with questions were instructed to contact their local BioMerieux representative.
For questions regarding this recall call 314-731-8526.
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
Component, external, limb, ankle/foot - Product Code ISH
Causa
The threads of the outer tube of the shock module of lp rotate are too short, resulting in insecure assembly. use of the product may cause the patient to fall with continued use, as the shock module can become loose from the foot blade.
Acción
The firm's recall letter states the following instructions:
Immediately examine inventory and quarantine product subject to the recall. In addition the firm asks if further distributed to identify the customers and notify them of the recall. The firm states that notification may be enhanced by providing a copy of the letter.
The firm states that the recall notice needs to be passed along to all those who need to be aware.
The firm also states that if customers are wearing a faulty product that they recommend them scheduling a visit to have the product replaced with a new LP Rotate that is currently available. The firm states that they can also arrange pick-up of defected products.
For any questions the firm provides a customer service contact: Jamie Dutter, Senior Customer Service 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.
The firm sent customers "Urgent: Medical Device Recall" letters, dated December 29, 2014. The letter described the problem, as well as, the actions to be taken. A Carestream Health service representative will contact customers to schedule a visit to inspect the affected devices. Questions or concerns should be directed towards the Carestream Customer Care Center in the U.S. at 1-800-328-2910.
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 firm sent customers "Urgent: Medical Device Recall" letters, dated December 29, 2014. The letter described the problem, as well as, the actions to be taken. A Carestream Health service representative will contact customers to schedule a visit to inspect the affected devices. Questions or concerns should be directed towards the Carestream Customer Care Center in the U.S. at 1-800-328-2910.
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
Accelerator, linear, medical - Product Code IYE
Causa
The exactrac 6.X patient positioning system may incorrectly position the patient when using the exactrac cone beam ct (cbct) with a truebeam-specific optional subvolume-cbct.
Acción
BrainLab sent an FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated February 16, 2015, to all affected customers. The letters included instructions for customers to: 1) Do not use any actively re-reconstructed CBCT subvolumes from the Varian TrueBeam system with the Brainlab ExacTrac 6.x CBCT Import & Alignment Software module; 2) Import exclusively original, not modified, CBCT volumes into ExacTrac to use for patient positioning; and, 3) Continue to verify any ExacTrac CBCT-based correction using the ExacTrac X-ray verification and/or an external IGRT procedure as mandatory.
Brainlab provided existing potentially affected ExacTrac v.6.x CBCT Import & Alignment Software customers (with a Varian TrueBeam system) with the product notification information. Brainlab will provide a software update with this issue solved to affected customers. Brainlab will actively contact the customer starting August 2015 to schedule the update installation.
For further questions please call Customer Hotline + 49 89 99 15 68 44 or 1-800 597-5911 ( For US Customers only)
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
Connector, airway (extension) - Product Code BZA
Causa
Product is mislabeled as double swivel connector with suction port and is actually double swivel connector without suction port. if the incorrect component is not identified prior to clinical use, the incorrect connector would be replaced during the case without risk to the patient and could result in a short delay of the procedure.
Acción
Kingsystems sent an Urgent Medical Device Recall letter dated February 17, 2015 to affected customers. The letter identified the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call your King Systems customer service representative at 800.642.5464.
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.
Asfotase alfa (strensiq) interferes with certain tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.
Acción
The firm TOSOH Bioscience Inc., sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 23, 2018 to affected customers. The letter described the product, problem and action to be taken. The customers were instructed to do the following:
*Based on our revised labeling, the assays identified in Table 1 should not be used for patients who are being treated with Asfotase Alfa.
" For patients that are being treated with Asfotase Alfa, use an alternative test method that does not utilize alkaline phosphatase technology.
" Inform all medical professionals that assays utilizing alkaline phosphatase-based technologies must not be used for patients receiving Asfotase Alfa treatment. Continue to use the assays listed in Table 1 for any patients who are not receiving Asfotase Alfa treatment.
" Complete and return the attached Acknowledgement Form to Tosoh Bioscience, Inc., within 15-days of receiving this notification via Fax: 1-650-636-8651, Email: biorecallresponse@tosoh.com or Regular mail: 3600 Gantz Rd., Grove City, OH 43123.
" Maintain this notification with your laboratory records and forward this information to others who may have received this product.
" If you have obtained unexpected test results or received any complaints of illness or adverse events associated with the use of the products identified in the table above, contact Tosoh Technical Support 24 hours a day, seven days a week at (800) 248-6764.
Should you have any questions regarding this medical device recall, please feel free to call (800) 248-6764 or email: bernadette.oconnell@tosoh.com. Monday - Friday, from 9:00 AM to 5:00 PM (PST).
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.
Images belonging to a different patient were used for the production of the patient specific surgical guide. the incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
Acción
Materialise N.V. sent an email on February 4, 2015, to the the affected distributor regarding the reason for the recall, affected product, and instructions for removing the affected product. For questions regarding this recall call 321-639-6611.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Potential breach of the sterile barrier packaging.
Acción
Bard sent an Urgent Medical Device Recall letter on January 30, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter also requested that a sub-recall should be conducted if the product was further distributed. The letter also included a response form which is to be returned to Bard.
This voluntary recall is only for the lots noted above with the affected product catalog number. Notifications of this recall are being sent to all affected accounts of Bard Medical Division, Inc. If you have further distributed this product, you are required to notify your accounts of the voluntary recall. If you have any questions or need assistance in notifying your accounts about the correction, please call 1-770-784-6471.
We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action.
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
Staple, fixation, bone - Product Code JDR
Causa
The firm is recalling togglelocs and ziploops manufactured in may and july of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.
Acción
Biomet sent an Urgent Medical Device Recall Notice letter dated March 4, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediate locate and discontinued use of the product and its return to Biomet. Customers may contact Field Action Specialist, Regulatory Compliance,at (574) 372-1570.
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
Staple, fixation, bone - Product Code JDR
Causa
The firm is recalling togglelocs and ziploops manufactured in may and july of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.
Acción
Biomet sent an Urgent Medical Device Recall Notice letter dated March 4, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediate locate and discontinued use of the product and its return to Biomet. Customers may contact Field Action Specialist, Regulatory Compliance,at (574) 372-1570.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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, tomography, computed - Product Code JAK
Causa
The firm was notified that the failure of the ups accessory devices used in conjunction with computed tomography x-ray systems and diagnostic imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.
Acción
On 3/9/2015 the firm sent Urgent Field Safety Notices Medical Device Correction letters to their customers.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.
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.
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
virus test kit - Product Code N/A
Causa
Lusys laboratories is recalling ebola virus one step test kits to stop and prevent further use of these devices. the ebola virus one-step test kits have not yet been cleared, approved or authorized by the fda for diagnostics purposes.
Acción
LuSys Laboratories sent an Urgent Medical Device Recall letter dated March 13, 2015, to all affected customers informing them that the Ebola Virus One Step Test Kits are not approved by FDA for diagnostics purposes. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to discontinue use and return the products to LuSys Laboratories. Customers are instructed to fax back the acknowledgement and Receipt Form to 1-858-866-1688.
For questions regarding this recall call 858-546-0902.