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 medical devices that are to be steam sterilized (autoclaved) by the facility prior to use. Sterilized devices may be stored and transferred within the facility in the container per the healthcare facilities protocols. Integra provides these items to users as either as a tray and lid combination, just a tray, or just a lid.
This recall has been terminated (originally issued September 11, 2014).
- Company
- Integra York Pa, Inc
- Recall Initiated
- July 30, 2014
- Posted
- September 11, 2014
- Terminated
- March 10, 2015
- Recall Number
- Z-2624-2014
- Quantity
- 84
- Firm Location
- York, PA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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
Lot / Code Info
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
Root Cause
Employee error
Action Taken
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. For questions regarding this recall call 717-840-9335.