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
Ventilator, continuous, facility use - Product Code CBK
Causa
Covidien is issuing a voluntary field action for all puritan bennett 980 ventilators due to occasional gui transient resets that last approximately 30 seconds.
Acción
Covidien sent an Urgent Field Safety Notice on January 12, 2015, to all affected customers. Customers were requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Covidien is updating software that will modify ventilator alarms and status display messages during a GUI reset. The Puritan Bennett 980 Ventilator Operator Manual will be updated to delete,replace ventilator during a GUI transient reset, and to inform users to monitor the secondary status display until the primary display refreshes. Covidien will communicate with customers when the software and operator manual updates are available.
Customers with questions were instructed to contact Technical Support Department at 800-255-6774, option 4, and then option 1.
For questions regarding this recall call 303-876-8870.
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
Table, radiologic - Product Code KXJ
Causa
The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality.
Acción
Planned Action by the firm:
1. You will send out a customer notification letter that identified the software corrective actions and that indicates that these corrective actions will be provided to the end-user free of charge.
2. You will implement a corrective software patch so that kV and mA manual adjustments from the generator console are inhibited, and consequently no high-level control modality is allowed. In AERC, high-level control is already disabled. A Field Service Engineer is to implement the software patch according to the corrective action plan
1. Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR
The system shall be modified upgrading the generator power firmware which will inhibit the high-level control bringing the system into compliance.
This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification.
2. You will implement the corrective software patch to inhibit high-level control according to the corrective action plan by June 22, 2015.
For further questions please 203.262-8836
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 for delay in surgery and/or ball bearings to be left in the wound. repeated cycles of sonic cleaning can break down the ball bearing retention feature (swage) on the shim. to prevent this, tasp shims must be manually cleaned and inspected per product insert, 87-6203-991-22.
Acción
Zimmer sent an URGENT MEDICAL DEVICE CORRECTION notifications letter dated December 11, 2014 to affected distributors via electronic mail, and all hospital Risk Managers and distributors with affected inventory via courier. The letter identified the affected product, problem, instructions for responding to the formal recall notification.and actions to be taken. For questions call the customer call center at 1-800-348-2759.
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
Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
Causa
In may 2013, the original recall was initiated due to complaints the hand switch for the electric pen drive was not labeled correctly, and the on and lock labels were interchanged.
Acción
Synthes sent an Urgent Medical Device Recall Notice, dated December 19, 2014, to all affected customers to provide updated information on additional lots identified. Customers were instructed to examine their inventory for the affected product, remove from inventory, and return them to Synthes immediately for replacement. Customers were instructed to call Synthes to obtain a Return Authorization (RA) Number, complete the Verification Section at the end of the letter, and return the Verification Form with the product to: Credit/Returns, Synthes 1101 Synthes Avenue Monument, CO 80132. Customers with questions were instructed to call 610-719-5450 or email FieldAction@synthes.com. For questions regarding this recall call 610-719-5000.
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.
Labeling; the affected product packaging is incorrectly labeled as being a cuffed oral et tube; the correct product labeling is uncuffed nasal et tube.
Acción
Teleflex Medical sent an " Urgent Medical Device Recall Notification" dated January 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
They were instructed to immediately discontinue use and quarantine any of the affected products, return the product and to complete the enclosed Recall Acknowledgement Form even if they do not have the affected product in stock. Distributors were instructed to communicate the recall to any of their customers who may have received product included within the scope of the recall. Have the customers return any affected product to them, together with a completed Recall Acknowledgement Form.
Teleflex Medical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
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
Condenser, heat and moisture (artificial nose) - Product Code BYD
Causa
Defects: cracks that may occur in the center of the corrugated flex tube of the 15 mm and 22 mm iso female connector.
Acción
Consignees were notified by an Urgent - Field Safety Notice, dated 01/12/2015. The letter identified the affected devices, a description of the problem, and actions to be taken. Customers were asked to check their inventory for any affected product, to cease use and distribution, and immediately quarantine any affected product. Customers are to complete and return the Acknowledgement form and to their local MAQUET representative, who provide a return number. A credit will be issues upon receipt of the affected product. Customer should contact their local MAQUET representative at fieldactions@maquet.com with questions or for support 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 labelling of units from the affected lot indicates that it contains a size 5 lma supreme (new cuff), but may contain a size 4 lma supreme (new cuff).
Acción
Teleflex sent an Urgent Medical Device Recall Notification letter dated January 13, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products and to return it to Teleflex Medical. Customers were asked to complete the enclosed Recall Acknowledgement Form via fax even if they do not have the affected product in stock. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
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.
Carefusion is recalling the smartsite low sorbing infusion set due to disconnection and leakage issues.
Acción
CareFusion sent an Urgent Medical Device Recall Notification letter dated January 13, 2015, to all affected customers. The letter informs the customers of the problems identified and the actions to be taken. Customers were instructed to complete and return to CareFusion the recall response card. Customers with questions were instructed to CareFusion: Recall related questions, (888) 562-6018; Adverse Event Reports, (888) 812-3266; Technical Questions regarding the Alaris System, (888) 812-3229.
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
barcode scanner used with in vitro diagnostic analyzer - Product Code N/A
Causa
In combination with the batch programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup positions within a sample tray. this issue only occurs when using the batch programming option; all other sample programming options function as intended.
Acción
On 12/29/2014, Customer letter (Ref. CL2014-315) was sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and provided with instructions for reconfiguring their Barcode Scanners.
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.
Shaft breaks so that adequate patient specimen sample cannot be obtained.
Acción
Consignees were initially notified of the recall via phone on 12/23/2014 and 12/29/2014. They were informed that the product may have been over exposed to gamma radiation, resulting in brittle sticks. They were instructed to not use the product for patient sampling and to return any product remaining in inventory to Puritan.
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.
Current labeling indicates that cycling improves device longevity in every programming scenario. however, enabling cycling at certain parameter settings may decrease the device battery longevity. with cycling enabled, longevity estimate displayed on the model 8840programmer may be inaccurate.
Acción
Consignees were sent a Medtronic {Medical Device Correction" letter dated January 9, 2015. The letter was addressed to Healthcare Professional. The letter described the issue and the product involved in the the recall. The letter also listed the Occurrence of the problem and labeling update. A Physician Reply Form was included which requested consignees to return the form to Medtronics. For questions they can contact Medtronic Neuromodulation Technical Services at 1-8007070944 weekdays 7 am 6 pm Central time. A second "Physician Notification Confirmation Form" was included to be completed by Medtronic Representatives.
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.
Internal labeling review found that the ifu for the harmonic ace incorrectly instructs the user on how to manually open the grips.
Acción
A Field Safety Notice entitled, Urgent Medical Device Correction, and dated, January 21, 2015, were sent to customers. The letter identified the problem and the reason for the recall as well as the risk to health. Customers are asked to ensure that all affected personnel are informed of the notice. Additionally, customers are to discard their current Harmonic Ace IFUs. Customers are to refer to the specified manual, reference guide, and instruction card mentioned in the letter. A copy of the notice is to be retained with the da Vinci Standard, S or Si user manual. Intuitive Surgical will remove the Harmonic ACE IFU from all future shipments of the product. Representatives will be available by phone to answer questions related to the Correction.
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.
Internal labeling review found that the ifu for the harmonic ace incorrectly instructs the user on how to manually open the grips.
Acción
A Field Safety Notice entitled, Urgent Medical Device Correction, and dated, January 21, 2015, were sent to customers. The letter identified the problem and the reason for the recall as well as the risk to health. Customers are asked to ensure that all affected personnel are informed of the notice. Additionally, customers are to discard their current Harmonic Ace IFUs. Customers are to refer to the specified manual, reference guide, and instruction card mentioned in the letter. A copy of the notice is to be retained with the da Vinci Standard, S or Si user manual. Intuitive Surgical will remove the Harmonic ACE IFU from all future shipments of the product. Representatives will be available by phone to answer questions related to the Correction.
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
Elekta has identified a batch of securing bolts that fix the gantry counter frame weight stack may fail.
Acción
Elekta sent an Urgent Important Field Safety Notice on January 7, 2015, to all affected customers. Elekta recommended that customers replace the M20 x 50 MM bolts marked 'OF' on the gantry counterbalance frame immediately. The digital linear accelerator must not be used until these 'OF' bolts are replaced. Elekta recommended that customers put the machine in a parked position at 0, and attach the gantry locking straps. A Modification kit will be available as soon as possible which contains the correct bolts. Customers were instructed to complete the Important Field Safety Notice Acknowledgement form and return to their local Elekta Office or Representative. Customers with questions were instructed to contact their local Elekta representative.
For questions regarding this recall call 404-993-5886.
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 packages may contain foreign material (black particles).
Acción
Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
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 packages may contain foreign material (black particles).
Acción
Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
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 packages may contain foreign material (black particles).
Acción
Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
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 packages may contain foreign material (black particles).
Acción
Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
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 packages may contain foreign material (black particles).
Acción
Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
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 packages may contain foreign material (black particles).
Acción
Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
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 packages may contain foreign material (black particles).
Acción
Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
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 packages may contain foreign material (black particles).
Acción
Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
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 packages may contain foreign material (black particles).
Acción
Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
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 packages may contain foreign material (black particles).
Acción
Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
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 packages may contain foreign material (black particles).
Acción
Teleflex sent and Urgent Medical Device Recall Notification letter dated January 14, 2015 to all affected customers. The letter identified the affect product, problem and actions to be taken. Customers were instructed to immediately discontinue use and quarantine any products with the affected catalog numbers and lot numbers. Customers were asked to complete and return the enclosed Recall Acknowledgement Form. For questions contact your local sales representative or Customer Service at 1-866-246-6990.