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
Pump, infusion - Product Code FRN
Causa
Smiths medical became aware that certain non flow-stop cadd(r) medication cassette reservoirs may have been manufactured with an incorrect pressure plate.
Acción
The firm initiated the recall via letter during the week on 09/25/2017.
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
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
Causa
The peristaltic head tubing placed on the architect c4000, c8000, and c16000 has the possibility to leak due to a manufacturing issue associated with the tubing connector.
Acción
All worldwide ARCHITECT Clinical Chemistry System customers with impacted instruments will receive the
Product Correction Letter dated, 9/29/17. A customer reply is requested from all affected 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.
A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. after the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a cocrmo screw included as a component of the implant, which contains nickel.
Acción
The firm contacted the surgeon who received / implanted the device. The product has been implanted, so it is not subject to being returned.
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
Pump, infusion - Product Code FRN
Causa
There have been reported incidents of fluid leaks at the luer connection. leaks have been confirmed to originate from, or near, the reservoirs clearcolored female luer connecter.
Acción
WalkMed sent an Urgent Medical Device Recall letter dated September 27, 2017, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: discontinue distribution of any affected products.
Contact any customers to whom these products were dispensed and inform the customers accordingly based on the following items.
Wear gloves and other personal protective equipment as needed to avoid contact with leaking infusion fluids when handling the product.
Collect and return affected products using proper biohazardous material handling where applicable.
Complete the enclosed Acknowledgement Form to record the return or destruction of the product and return to WalkMed LLC.
Customers with questions were instructed to call 720-351-4966.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
A specific lot of the flexflowtm venous
cannula, 200-200, is being recalled because it is sharper or pointier than expected.
Acción
LivaNova sent an Urgent Medical Device Recall letter dated September 28 2017, to all affected consignees. The letter instructed customer to isolate products belonging to the lot involved. The level of the effectiveness check is Level A, where 100% of the consignees will be contacted. The customers were requested to send back any affected product and to complete the attached Customer Response Form by fax to 303-467-6502 or by email to USFSN@livanova.com. For questions customers were advised to contact Customer Service at 800-.650-2623.
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
Aid, transfer - Product Code IKX
Causa
The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
Acción
Medline Industries sent an Immediate Action Required Recall Notification letter via First Class mail dated August 10, 2017. The recall was later expanded and customers were notified via letter of the additional lots dated August 21, 2017. Instructions in both letters included to check inventory and quarantine any affected product, complete and return the included response form, coordinate the return of all affected product, and notify customers if the product was further distributed.
Additional customers were identified and notified of the recall via the same process on September 19th, 2017. For further questions, please call (866) 359-1704.
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
Aid, transfer - Product Code IKX
Causa
The locking mechanism on the belt may fail to secure/hold the strap when in locked position potentially allowing the belt strap to slip through the buckle.
Acción
Medline Industries sent an Immediate Action Required Recall Notification letter via First Class mail dated August 10, 2017. The recall was later expanded and customers were notified via letter of the additional lots dated August 21, 2017. Instructions in both letters included to check inventory and quarantine any affected product, complete and return the included response form, coordinate the return of all affected product, and notify customers if the product was further distributed.
Additional customers were identified and notified of the recall via the same process on September 19th, 2017. For further questions, please call (866) 359-1704.
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
General surgery tray - Product Code LRO
Causa
Resource optimization & innovation, llc (roi) received a recall notice from bd for an incorrect label on 3ml chloraprep with tint, product code (ref) 260415ns, ndc 054365-400-11, lot 7096622. the label mix is at the unit level where a "chloraprep one-step" unit label was incorrectly used on a certain percentage of the impacted lot instead of the correct "chloraprep with tint" label.
the recall notification was issued by bd on september 15, 2017 and was received by roi on september 18, 2017. because the 3ml chloraprep with tint product is contained within select roi regard custom surgical packs, roi is conducting a recall of the affected roi regard custom surgical packs.
Acción
Customer was notified of the recall via email on September 25, 2017.
Instructions included identify and quarantine any affected products, notify ROi by completing and returning the completed notification form, coordinating the issuance of supplemental labeling which will instruct the end user to remove and discard the recalled ChloraPrep at the time of use. For further questions, please call (417) 820-2793
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
Cardiopulmonary resuscitation aid kit - Product Code OEV
Causa
The mask component on various lots of the resuscitation devices have been identified as having the
potential to exhibit a sticking condition which may result in a difficult to/unable to disconnect condition of the
mask from the elbow of the resuscitator.
Acción
The firm, Vyaire Medical, sent an "URGENT RECALL NOTICE" letter on 04/27/2017 and again on 06/08/2017 for the expansion of the recall to its Customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect current inventory on-hand and immediately perform a 1OO% physical inventory of the product to identify and be removed; complete and return the Customer Response Form by Fax to: (312) 949.0972 or email to:GMB-GLB-VSFieldActions@CareFusion.com.; destroy all affected product in accordance with your facility's destruction protocol; and for replacements, contact your distributor Armstrong Medical direct at (800)323.4220 x129.
For any additional questions and support concerning this voluntary recall, please contact Customer Advocacy Analyst at (224) 706.6829 or email: Kristina.Scheppa@CareFusion.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
Monitor,physiological,patient(without arrhythmia detection or alarms) - Product Code MWI
Causa
Intermittent communication between the host system and the flex cardio.
Acción
On August 2017 the firm sent letters to their consignees indicating the following:
This document contains important information for the continued safe and proper use of your equipment
Please review the following information with all members of your staff who need to be aware of the contents of this communication. It is important to understand the implications of this communication.
Please retain a copy with the equipment Instruction for Use.
-------------------------------------------
A problem has been detected in the Philips Xper Flex Cardio Patient Monitoring System ( Flex Cardio ) that, if it were to recur, could pose a risk for patients or users. This Field Safety Notice is intended to inform you about:
" what the problem is and under what circumstances it can occur
" the actions that should be taken by the customer / user in order to prevent risks for patients or users
" the actions planned by Philips to correct the problem.
Because of intermittent communication between the host system and the Flex Cardio, it is possible for any of the following conditions to occur:
" Inability of the Flex Cardio to connect to the host system.
" Boom Monitor (display) may not display all active waveform and/or vital sign data.
" Delayed audible and visual alarms at the Flex Cardio and Boom Monitor respectively, due to a mismatch between the alarm limits on the host system and the Flex Cardio/Boom Monitor.
" After patient admission and case initiation at the host system, the case may not be fully transmitted to the Flex Cardio. In this case, the Boom Monitor in the exam/procedure room will display vital sign data, but the Flex Cardio will not provide audible alarms.
" After patient discharge and case termination at the host system, case termination may not be transmitted to the Flex Cardio. In this case, the Boom Monitor in the exam/procedure room will continue to display vital sign data, and the Flex Cardio will continue to provide audible alarms.
Our re
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
Agent, tooth bonding, resin - Product Code KLE
Causa
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.
Acción
Customers were sent recall notification letters on approximately 09/28/2017. The letter identified the affected device and discussed the reason for the recall. Instructions included discontinuing use of the product, and returning it to Cosmedent. The firm will issue a credit or refund for the recalled 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.
Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.
Acción
Medtronic sent an Urgent Medical Device Recall letter dated September 2017, to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and return the enclosed Customers Confirmation form. For questions contact Technical Services at 1-888-854-0978.
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
Manual antimicrobial susceptibility test systems - Product Code JWY
Causa
Qc failures (mic out of range high) for s.Aureus atcc 29213 strain on etest ox 256 (oxacillin) foam packaging (ref. 520558, 520518) reported. the product behavior could lead to false resistant results.
Acción
BioMerieux sent an Urgent Field Safety Notice on April 30, 2017.
Short-term Action: Subsidiaries and distributors are required to discard all ETEST¿ OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) under (PSS#3320) remaining in their inventory. In order to avoid any backorders on the field during the transition to the SPB configuration that is conformed to the expected specifications, Subsidiaries and Distributors were instructed to distribute the Urgent Field Safety Notice (customer letter) to inform Medical customers and Veterinary customers that have received and will receive the product. The Urgent Field Safety Notice informed customers of the non-conformity along with instructions to continue the use of the impacted products with recommendations described in customer letter, and in addition, for the Medical Customers, to discuss any concerns they may have regarding previously reported Susceptible results on the impacted batches Listed Table 1 with their Laboratory Medical Director to determine the appropriate course of action. Long-term Action: A CAPA (PR#1101306) has been initiated in order to identify the root-cause and prevent the issue to recur. They were instructed to complete and return the attached Acknowledgement Form by Fax to confirm receipt of this notice. For further questions, please call (314) 731-8694.
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
Manual antimicrobial susceptibility test systems - Product Code JWY
Causa
Qc failures (mic out of range high) for s.Aureus atcc 29213 strain on etest ox 256 (oxacillin) foam packaging (ref. 520558, 520518) reported. the product behavior could lead to false resistant results.
Acción
BioMerieux sent an Urgent Field Safety Notice on April 30, 2017.
Short-term Action: Subsidiaries and distributors are required to discard all ETEST¿ OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) under (PSS#3320) remaining in their inventory. In order to avoid any backorders on the field during the transition to the SPB configuration that is conformed to the expected specifications, Subsidiaries and Distributors were instructed to distribute the Urgent Field Safety Notice (customer letter) to inform Medical customers and Veterinary customers that have received and will receive the product. The Urgent Field Safety Notice informed customers of the non-conformity along with instructions to continue the use of the impacted products with recommendations described in customer letter, and in addition, for the Medical Customers, to discuss any concerns they may have regarding previously reported Susceptible results on the impacted batches Listed Table 1 with their Laboratory Medical Director to determine the appropriate course of action. Long-term Action: A CAPA (PR#1101306) has been initiated in order to identify the root-cause and prevent the issue to recur. They were instructed to complete and return the attached Acknowledgement Form by Fax to confirm receipt of this notice. For further questions, please call (314) 731-8694.
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,network and communication,physiological monitors - Product Code MSX
Causa
Philips mrx devices have an etco2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the etco2 or co2 waveform (capnogram).
Acción
The Philips Urgent Medical Device Correction notification/ Field Safety Notice informs customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue. The correction will consist of providing a hardware correction, free of charge, for all units affected by this issue.
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 being recalled exceeded the weight previously tested leading to a possibility of damage to the package and/or a compromised sterile barrier.
Acción
The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL"-Lot Specific letter dated 8/1/2017 to its Customers via email and/or FedEx. The letter describes the product, problem and actions to be taken. The Instructions to Distributors, Sales Representatives, and Distributor Operation Managers included to ensure affected team member are aware of the contents of the notification letter, immediately locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement form by email to: corporatequality.postmarket@zimmerbiomet.com., return all affected product, and note if there are any hospitals and/or surgeons for which need to be notified.
Instructions for Risk Managers and surgeons are to ensure affected personnel are aware of the contents of the notification letter, quarantine any affected product on hand, complete and return the Certificate of Acknowledgement form by email to: corporatequality.postmarket@zimmerbiomet.com., and return any affected product on hand.
For questions or concerns, please call the 411 call center at 1-574-371-3071 between 8:00 am and 5:00 pm EST, Monday through Friday or email corporatequality.postmarket@zimmerbiomet.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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
During the rework process for the april 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. this could prevent the product assembly with the mating screw and targeting jig.
Acción
Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
During the rework process for the april 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. this could prevent the product assembly with the mating screw and targeting jig.
Acción
Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
During the rework process for the april 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. this could prevent the product assembly with the mating screw and targeting jig.
Acción
Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
During the rework process for the april 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. this could prevent the product assembly with the mating screw and targeting jig.
Acción
Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
During the rework process for the april 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. this could prevent the product assembly with the mating screw and targeting jig.
Acción
Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.
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
Material, tooth shade, resin - Product Code EBF
Causa
Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
Acción
The firm sent letters to consignees on August 3, 2017 instructing them to segregate the recalled product and arrange for a replacement of stock.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
During the rework process for the april 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. this could prevent the product assembly with the mating screw and targeting jig.
Acción
Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
During the rework process for the april 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. this could prevent the product assembly with the mating screw and targeting jig.
Acción
Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.
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
Rod, fixation, intramedullary and accessories - Product Code HSB
Causa
During the rework process for the april 17, 2017, field action, it was detected that the set screw and sleeve assembly which are designed to have an interference fit, were no longer in the installed location. this could prevent the product assembly with the mating screw and targeting jig.
Acción
Customers were notified via FedEx and/or email on approximately 08/07/2017. Instructions include ensure appropriate personnel are notified of the recall, locate and quarantine affected product in inventory, complete and return the Certification of Acknowledgement, return all affected product, and provide the names of hospitals or customers that would have received this product if further distributed.