Recall Z-2624-2014 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Integra York PA, Inc
Integra Container Lid, Size, Red; Container Lid, Size, Blue; Container Lid, Size, Red; Container Lid, Size, Gold; Container Lid, Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524, 730621, 730622 The Integra Sterilization Container is intended for use in hospitals and healthcare facilities to contain other medi
| Date | Sep 11, 2014 (initiated Jul 30, 2014) |
| Status | Terminated |
| Reason | Integra LifeSciences has identified through an internal investigation that some colored lids for Integra container systems were not yet cleared by the FDA for sale and were inadvertently distributed. |
| Root cause | Employee error |
| Action | Integra sent an Urgent Voluntary Medical Device Recall letter dated July 30, 2014, to the affected customer. The letter identified the product, the problem, and the action to be taken by the customer. The customer was instricted if they have distributed the affected product, they should identify those customers adn forward a copy of the Integra Medical Device Recall Notice to them. The customer was also instructed to complete the attached form and return by email FCA@integralife.come or FAX to 1-609-275-9445. For questions the customer was asked to contact Customer Service at 1-855-532-1723. |
| Quantity | 84 |
| Distribution | US only to one repacker/relabeler and three medical facilities. The relabeler was identified as: KLS Martin, 11201 St. Johns Industrial Parkway S, Jacksonville, FL 32246 (904) 641-7746 |
| FDA record | Open on fda.gov |