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
Protector, skin pressure - Product Code FMP
Causa
The gel-filled gel-e donut and squishon product line has received a number of complaints about visible mold. the mold detected was determined to be cladosporium and penicillium fungi, which are commonly found molds.
Acción
Childrens Medical Ventures sent an Urgent Medical Device Recall letter dated May 28, 2014, to affected customers via UPS. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to review entire inventory and inspect for signs of visible mold, do not open the packaging to do the inspection, the mold should be seen through the transparent outer packing, complete and return the reply form provided on the last page of the letter, dispose of any product containing mold per your facilitys environmental guidelines, do not return any product to your Distributor or to Philips/Childrens Medical Ventures.and credit for disposed product will be given. If you need any further information or support concerning this problem, please contact your Distributor at the following phone number:
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
Screw, fixation, bone - Product Code HWC
Causa
Small bone innovations (sbi) is recalling all lots of 3.0/4.0mm autofix" cannulated compression screw system sets, implants, and instruments to update the ifu.
Acción
Small Bone Innovations sent an Urgent Medical Device Recall letter, dated May 19, 2014, to all affected customers. The letter that described the product problem, and the action to be taken by the customer. was sent to sales reps, stocking customers, and distributors. Customers were instructed that a copy of the IFU should be stored with each unpackaged AutoFIX 3.0/4.0mm Compression Screw Sets, Implants, or Instruments in their current inventory.
Customers were instructed to return all packaged affected product which would be replaced by the firm with an updated IFU. A Federal Express return label was included to facilitate the return shipment. Customers were instructed to complete, sign, and return with the product the Return Material Authorization (RMA) document.
For questions regarding this recall call 215-428-1791.
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 conducting a medical device field correction for specific puritan bennett 840 ventilators due to customer reports of loss of graphical user interface (gui) display information while the ventilator continues to provide breath support.
Acción
Covidien sent an Urgent Medical Device Voluntary Field Correction letter dated 6/13/2014, to all affected customers. The letter identified the product the problem and and the action needed to be taken by the customer.
Customers are requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Service professionals will be identifying the affected PSUs and replacing them. The removed PSUs will be destroyed.
To verify whether your devices are affected by this field safety corrective action and to initiate the process to receive the actions mentioned above, please complete the attached verification form and fax it to the Covidien contact indicated on the form. If you need further assistance, contact our Technical Support Department @ 1-800-255-6774, option 4, then option 1.
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
Stimulator, muscle, powered - Product Code IPF
Causa
Zynex notified customers that a malfunction in the if 8000 can result in the device ceasing to operate, and in some instances,overheating and becoming hot to the touch.
Acción
Consignees were notified via letter on 6/25/2009. The letter identified the reason for the recall, and stated that customers could contact customer service at 1-866-940-7030 if they encountered any difficulties with the affected product. Otherwise, they could continue using the product as they have in the past.
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
In the case of a loss of gui display due to a backlight inverter pcba failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. however, there is a loss of display and thus there is a necessity to move the patient to another ventilator.
Acción
Covidien will be issuing the Product Notification letter in 2014. Customers are requested to forward the letter to anyone they may have transferred or assigned for use one of the 9.4 display configuration ventilators. Service engineers will be replacing the BLI PCBA with a new design containing the 1.0 ampere fuse and then destroying the old PCBA. Ventilators replaced with newer models under the commercial program will be returned to Covidien for disposal.
Should you have any questions regarding this letter or to report any issues with the Puritan Bennett" 840 ventilator contact our Technical Support Department at 1-800-255-6774, option 4, then option 1, to ensure proper device reporting procedures are followed. Thank you for your prompt attention to this matter.
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.
Sterigear notifed customers of circumstances in which the fig leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.
Acción
SteriGear, LLC sent a special note to all affected customers between January 12, 2011 and September 28, 2012. The note identified the product, the problem, and the action to be taken by the customer. Customers were instructed on how to reposition the inlet tube. Customers with questions were instructed to contact Director of Product Development at 801-607-3211. No correction or removal was performed.
For questions regarding this recall call 801-607-3209.
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.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Acción
Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
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.
Software version 02-26, when used with the central nursing station (cns) 6201, (pu-621 ra) may unexpectedly and without warning reboot, resulting in a period of approximately 3 minutes during which time the system does not display patient data and does not emit alarms based on that data should they be appropriate.
Acción
Nihon Kohden sent an Urgent Medical Device Safety Notification and Field Correction letter dated June 3, 2014 to affected customers. Recall notification letter, dated June 3, 2014 was hand-delivered to site by Nihon personnel. The letter provided the following information: product description with codes and software version, reason for recall, field correction information and actions to be taken, MedWatch reporting information, and contact information for recall.
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
Test,natriuretic peptide - Product Code NBC
Causa
Alere san diego is recalling alere triage bnp calibrators for the beckman coulter access family of immunoassay systems because the bottle labeled as calibrator level 5 actually contains calibrator level 4. this results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected level 5 calibrator.
Acción
Alere sent an Urgent Medical Device Recall letter dated May 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The primary consignees were instructed to block all stock of the affected lot in their warehouses; discontinue use and return all stock on hand, complete the provided verification form to document receipt of the notice and quantity to be returned, contact their primary consignees and advise them of the required
discontinuation and return of the affected lot. For customers (or their sub-distributors) who have inventory on hand, Alere San Diego, Inc. will provide replacement product to the customer for the quantity of units that they must return.
Customers are instructed to complete the attached reply form with the amount of unused product that will be returned for replacement. Customers with questions are instructed to contact Alere San Diego at 9975 Summers Ridge Rd, San Diego, CA 92121, (877) 308-8287, triage.support@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.
A portion of the bbl crystal enteric/nonfermentor (e/nf) identification kits from lot numbers 3224281 and 3290379 are labeled with incorrect expiration dates.
a portion of these kits contain crystal inoculum fluid bottles that will expire prior to the date that was printed on the kit carton. the expiration date printed on the individual crystal inoculum fluid bottles is correct.
Acción
BD Diagnostic sent an Urgent Product Recall letter dated May 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed:
Please discard any outer kit boxes that are labeled with the incorrect expiration date. All components of the kit will perform as expected with the expiration dates on each component.
Our records indicate you may have been shipped a portion of the above-referenced product between August 23, 2013, and the present day.
Please complete the attached form whether or not you have any inventory remaining so that we may acknowledge your receipt of this notification. It is not necessary to contact BD by telephone. Simply complete and fax the form to: Attention: Regulatory Compliance, Fax: 410-316-4258.
If further assistance is needed, please contact the BD Customer Service Department at 1-800-675-0908. For all other inquiries, please contact the BD Technical Services Department at 1-800-638-8663.
Please accept our apology for any inconvenience this may cause. BD is committed to providing you with the highest quality products. Thank you for your continued support.
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;/ i )!.U fJJ aLA.
Thierry Guilltrt Gail Claiborne
Marketing / Regulatory Compliance
Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
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.
Stryker has received complaints from the field alleging instances where the in touch beds are hoisted or lifted from the floor and the casters have fallen off. the investigations into these casters have shown that in these cases the caster has broken on the top of the caster stem where the brake rod inserts into the caster. if more than one caster on a unit is damaged, brake functions can be affec.
Acción
On 06/30/1014 the firm sent "Urgent Medical Device Notification" 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.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Acción
Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
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.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Acción
Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
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.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Acción
Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
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.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Acción
Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
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.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Acción
Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
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.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Acción
Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
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.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Acción
Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
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.
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
Acción
Zimmer sent an Urgent Medical Device Recall letter June 2014 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate and quarantine any affected product and notify their Zimmer sales representative. Their Zimmer sales representative will remove the recalled product from their facility. For patients that previously had this product implanted, it is recommended that they continue their normal operative follow up routine. Customers with questions were instructed to call 1-877-946-2761.
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.
Multiple updates to user manuals, instructions for use (ifu), quick reference guides (qrg), and instrument release kits (irk) for use with the da vinci surgical system, instruments and accessories. removal of the emergency grip release wrench, part number 710142.
Acción
Intuitive Surgical sent a Field Safety Notice dated June 16, 2014, to all consignees affected by changes in labeling, IFU User manuals and QRG's. Consignees were instructed to take the following actions:
Ensure all appropriate personnel are fully informed of this Notification. Forward this letter to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci surgery procedures.
2. Use Attachment C to identify the labeling that has been updated.
3. No manuals or products should be returned. Discard old versions of the User Manuals, IFUs, and QRGs for which you have received updated versions.
4. Discard all versions of the Emergency Grip Release Wrench (Part Number 710142). Order additional IRKs from Intuitive Surgical as needed.
5. Complete and return the attached Acknowledgement Form to acknowledge that you have received the updated Labeling, IRKs, in-service and have discarded all previous versions of Labeling and the emergency grip release wrench. Please return the completed Acknowledgment Form within two days of the in-service.
6. Retain a copy of this Notice and the Acknowledgement Form for your records.
If you need further information or support concerning this recall, please contact your Intuitive Surgical Representative or Intuitive Surgical Customer Service at the numbers listed below:
North America: 800-876-1310 Option 3 (6 am to 5pm PST)
For questions regarding this recall call 408-523-2602.
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.
One lot of calcium hydroxide powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use.
Acción
Axcentria Pharmaceuticals sent an urgent medical device recall notice, dated June 5, 2014, was sent to customers and described the product, problem, and actions to be taken. Customers were asked to fill out and return the form included.
For questions customers were instructed to call 215-453-5055, ext 317.
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.
Multiple updates to user manuals, instructions for use (ifu), quick reference guides (qrg), and instrument release kits (irk) for use with the da vinci surgical system, instruments and accessories. removal of the emergency grip release wrench, part number 710142.
Acción
Intuitive Surgical sent a Field Safety Notice dated June 16, 2014, to all consignees affected by changes in labeling, IFU User manuals and QRG's. Consignees were instructed to take the following actions:
Ensure all appropriate personnel are fully informed of this Notification. Forward this letter to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci surgery procedures.
2. Use Attachment C to identify the labeling that has been updated.
3. No manuals or products should be returned. Discard old versions of the User Manuals, IFUs, and QRGs for which you have received updated versions.
4. Discard all versions of the Emergency Grip Release Wrench (Part Number 710142). Order additional IRKs from Intuitive Surgical as needed.
5. Complete and return the attached Acknowledgement Form to acknowledge that you have received the updated Labeling, IRKs, in-service and have discarded all previous versions of Labeling and the emergency grip release wrench. Please return the completed Acknowledgment Form within two days of the in-service.
6. Retain a copy of this Notice and the Acknowledgement Form for your records.
If you need further information or support concerning this recall, please contact your Intuitive Surgical Representative or Intuitive Surgical Customer Service at the numbers listed below:
North America: 800-876-1310 Option 3 (6 am to 5pm PST)
For questions regarding this recall call 408-523-2602.
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.
Multiple updates to user manuals, instructions for use (ifu), quick reference guides (qrg), and instrument release kits (irk) for use with the da vinci surgical system, instruments and accessories. removal of the emergency grip release wrench, part number 710142.
Acción
Intuitive Surgical sent a Field Safety Notice dated June 16, 2014, to all consignees affected by changes in labeling, IFU User manuals and QRG's. Consignees were instructed to take the following actions:
Ensure all appropriate personnel are fully informed of this Notification. Forward this letter to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci surgery procedures.
2. Use Attachment C to identify the labeling that has been updated.
3. No manuals or products should be returned. Discard old versions of the User Manuals, IFUs, and QRGs for which you have received updated versions.
4. Discard all versions of the Emergency Grip Release Wrench (Part Number 710142). Order additional IRKs from Intuitive Surgical as needed.
5. Complete and return the attached Acknowledgement Form to acknowledge that you have received the updated Labeling, IRKs, in-service and have discarded all previous versions of Labeling and the emergency grip release wrench. Please return the completed Acknowledgment Form within two days of the in-service.
6. Retain a copy of this Notice and the Acknowledgement Form for your records.
If you need further information or support concerning this recall, please contact your Intuitive Surgical Representative or Intuitive Surgical Customer Service at the numbers listed below:
North America: 800-876-1310 Option 3 (6 am to 5pm PST)
For questions regarding this recall call 408-523-2602.
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.
Multiple updates to user manuals, instructions for use (ifu), quick reference guides (qrg), and instrument release kits (irk) for use with the da vinci surgical system, instruments and accessories. removal of the emergency grip release wrench, part number 710142.
Acción
Intuitive Surgical sent a Field Safety Notice dated June 16, 2014, to all consignees affected by changes in labeling, IFU User manuals and QRG's. Consignees were instructed to take the following actions:
Ensure all appropriate personnel are fully informed of this Notification. Forward this letter to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci surgery procedures.
2. Use Attachment C to identify the labeling that has been updated.
3. No manuals or products should be returned. Discard old versions of the User Manuals, IFUs, and QRGs for which you have received updated versions.
4. Discard all versions of the Emergency Grip Release Wrench (Part Number 710142). Order additional IRKs from Intuitive Surgical as needed.
5. Complete and return the attached Acknowledgement Form to acknowledge that you have received the updated Labeling, IRKs, in-service and have discarded all previous versions of Labeling and the emergency grip release wrench. Please return the completed Acknowledgment Form within two days of the in-service.
6. Retain a copy of this Notice and the Acknowledgement Form for your records.
If you need further information or support concerning this recall, please contact your Intuitive Surgical Representative or Intuitive Surgical Customer Service at the numbers listed below:
North America: 800-876-1310 Option 3 (6 am to 5pm PST)
For questions regarding this recall call 408-523-2602.