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.
Water retention issues. units with filters that remain wet after the sterilization may compromised sterility.
Acción
On January 13, 2016 PMBS, LLC sent letters to their customers informing them of the correction. Per product's instructions for use, the SCORES cabinet is to be run for a minimun of a 4 minute sterilization cycle, followed by a 30 munites dry time followed by a 30 minutes door crack time. not all facilities generate completely dry SCORES filters following these instructions. It is imperative that the filters be checked in the Operation Room prior to useing the surgical instruments sterilised within the cabinet. If the filters are wet, do not use the contents. In the letter is a IFU addendum including instructions for running the equiptment with extended cycles. For more information please contact Ms. Michele Mauzerall, CEO at 908-300-7093.
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
Wheelchair, mechanical - Product Code IOR
Causa
Karman healthcare, inc. is recalling karma flexx wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets.
Acción
On 01/27/16 the firm sent out customer notification letters.
In the letter customers were informed that the firm was conducting a product update for original purchasers of KM8522. Customers were provided the following procedures for the product update:
1. Completed and signed notification must be returned to Karman Healthcare via fax at (626)-581-2335, or e-mail to edward@karmanhealthcare.com.
2. Following the received frame, customers may install their current wheels, and footrest onto the newly updated frame. Kindly package the used frame into the carton in the same manner the new carton was shipped.
3. A prepaid return shipping label is included with the letter, which customers may use to return the carton; or contact the firm's customer service line at (800)-805-2762 to have a trained representative schedule a pickup at no charge.
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
The tip of the stiffened cannula might break during use
and remain in the patient.
Acción
Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand.
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
Incorrect packaging. reports of packages labeled as 6.0fr actually containing 5.0fr devices.
Acción
On 1/20/2016, URGENT: MEDICAL DEVICE RECALL notifications were sent to the hospital Risk Management/Recall Administration via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Should you have any questions or concerns, please do not hesitate to contact Cook Medical Customer Relations at (800) 457-4500 or 1(812) 339-2235.
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 package for catalog item, a legion hemi stepped tibial wedge, 5 mm size 5-6 lt-lat/ rt-mdl, should include both a screw-on hemi stepped tibial wedge and two tibial wedge screws to affix the wedge to the tibial baseplate. a complaint was received indicating that the screws packaged with the wedge were too long.
Acción
The firm notified their direct consignee of the issue on 01/18/2016 by email. The notice requested return of the product.
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.
Aplicare castile soap towelettes included in the foley trays and mid stream specimen kits are contaminated with bacteria.
Acción
Medtronic/Covidien notfiied customersl via Federal Express on January 22, 2016,, The letter instructs customers to not use the Castile Soap Towelettes contained in the product kits listed on Attachment 1 and discard the affected towelettes. The Castile Soap packet included in these kits does not impact the integrity of the remaining products in the kit. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878.
For questions regarding this recall call 203-492-5000.
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.
Aplicare castile soap towelettes included in the foley trays and mid stream specimen kits are contaminated with bacteria.
Acción
Medtronic/Covidien notfiied customersl via Federal Express on January 22, 2016,, The letter instructs customers to not use the Castile Soap Towelettes contained in the product kits listed on Attachment 1 and discard the affected towelettes. The Castile Soap packet included in these kits does not impact the integrity of the remaining products in the kit. Questions or concerns, contact your Medtronic representative or Customer Service at (800) 882-5878.
For questions regarding this recall call 203-492-5000.
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.
Convenience kits contain an in-vision-plus needleless iv connector, code rym5001 that is being recalled by the manufacturer, rymed technologies, llc. a component molding abnormality may cause female luer threads to crack, leading to potential for the mating tubing set to become detached and for the administration to be interrupted. other components within these kits are not affected.
Acción
The firm, RyMed Technologies, LLC, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated 1/4/2016 to the affected customers via certified mail on 1/19/2016 with instructions for identifying and returning the affected product. The recall letter included a description of the reason for the recall, affected product, actions to be taken, and instructions for responding to the formal recall notification. The customers were instructed to discontinue distribution and/or use and return product to: RyMed Technologies, LLC, 6000 W. William Cannon Drive, Building B, Suite 300, Austin, TX 78749; that user facilities change the IV connector within 24 hours when lipids are being administered; if you further distributed any of the lots, contact your accounts, advise them of recall and return their outstanding stock, complete and return enclosed Acknowledgement and Receipt Form ASAP and no later than 10 business days via E-mail: amccutchen@rymedtech.com, Fax: 512-301-7338 or by mail to address above, Attention Recall Return Notification.
Please contact Director of Quality Assurance/Regulatory Affairs at (512) 301-7334 Ext.303 or email: ammccutchen@rymedtech.com should you have questions pertaining to recall notification.
Questions pertaining to Returning Product/Replacement Product contact Logistics Specialist at (512) 301-7334 Ext.309 or email svara@rymedtech.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.
Product may kink during use rendering the product unusable.
Acción
NATEC Medical ltd.sent an Urgent Medical Device Advisory Notice dated March 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Warnings:
This device should be used only by physicians who are experienced and have a thorough understanding of the clinical and technical aspects of angioplasty.
What action do you need to take:
1. Always use a guiding catheter when contralateral access is needed.
2. Always insert cautiously the PTA catheter inside the guiding catheter, and if any resistance is felt, the cause should be determined via fluoroscopy.
3. For contralateral procedure, the USE014OTW has to be preferred to Ebony 014 Rx.
NATEC Medical Ltd and our distributor US Endovascular are committed to keeping you and your healthcare professional informed of issues and solutions concerning our products and services. Should you have any questions regarding this or any other matter regarding your USE 014Rx PTA catheter, please do not hesitate to contact our distributor: US Endovascular at
(314) 341-4930.
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.
Ldpe bag containing the implant adheres to the highly polished implant surface.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633.
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.
Ldpe bag containing the implant adheres to the highly polished implant surface.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633.
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.
Ldpe bag containing the implant adheres to the highly polished implant surface.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633.
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
Software issue.
Acción
Philips Respironics has determined that affected devices may continue to be used in accordance with the device Instructions for Use and the Field Safety Notification that is being issued to customers. Philips Respironics will be providing a software update for affected devices free of charge. Customers will be notified by mail when the software update is available for download.
For further questions please call ( 724 ) 387-7500.
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
Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Causa
There were two potential interference conditions identified with the way the tubing set attaches to the inserter.
Acción
Stryker Spine sent an Urgent Product Removal letter dated December 17, 2015 to affected customers via Fed Ex priority overnight. The letter identified the affected product, problem and actions to be taken. Customers are asked to follow instructions included in the letter. The customer response form should be completed and sent back to email via Spine-RegulatoryActions@Stryker.com or Fax 855-632-9049. For questions call (201)749-8389.
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.
Ldpe bag containing the implant adheres to the highly polished implant surface.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633.
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.
Reported jamming of the impaction handle when assembled to the inserter guide at the threads.
Acción
Stryker Spine sent Urgent Product Removal notification letters to branches/agencies on 12/18/2015 via FedEx. The letters provided a description of the affected product, the issue, potential hazards and risk mitigations, and actions to be taken. Customers were asked to examine their inventory and hospital locations to identify the product and reconcile with the affected catalog and lot numbers provided. The Customer Response Form and Product Quantity Tracking Spreadsheet for Health Care Facilities should be completed and returned within five days of receipt of the notice to the e-mail or fax number provided. Questions can be directed to Nabil Riaz - Regulatory Compliance Specialist, Regulatory Compliance & Quality Systems at Nabil.Riaz@Stryker.com.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Ldpe bag containing the implant adheres to the highly polished implant surface.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633.
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.
Ldpe bag containing the implant adheres to the highly polished implant surface.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633.
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.
Ldpe bag containing the implant adheres to the highly polished implant surface.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633.
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.
Ldpe bag containing the implant adheres to the highly polished implant surface.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633.
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.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
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.
Ldpe bag containing the implant adheres to the highly polished implant surface.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633.
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
Clip, implantable - Product Code FZP
Causa
The clip in the applier may be missing a boss. a boss is the part of the clip that is used to hold the clip within the applier jaws prior to application.
Acción
Teleflex sent an Urgent Medical Device Recall Notification letter dated February 2, 2016 to customers. The letter identified the affected product, problem and actions to be taken. A separate letter was sent to distributors advising them to conduct a sub-recall. Customers were instructed to:
1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog numbers listed in the letter.
2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1- 855-419-8507, Attn: Customer Service or email to recalls@teleflex.com.This will document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex Medical.
3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will document receipt of the letter.
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.
Ldpe bag containing the implant adheres to the highly polished implant surface.
Acción
Zimmer Biomet sent an Urgent Medical Device Recall dated January 11, 2016, to all affected customers via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Customers with questions or concerns were instructed to contact customer service at 1-800-348-2759 or contact their Zimmer Biomet Sales Representative.
For questions regarding this recall call 800-447-5633.
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
Suture removal kit - Product Code MCZ
Causa
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
Acción
Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.