Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
This recall has been terminated (originally issued September 2, 2016).
- Recall Initiated
- August 24, 2016
- Posted
- September 2, 2016
- Terminated
- March 30, 2017
- Recall Number
- Z-2733-2016
- Quantity
- 710
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Integra LifeSciences has been notified of a medical device recall by Adaptive Surgical, LLC involving their Riverlon" Nylon 3-0 Sutures that are packaged in Integras Cranial Access Kits. It was found that product seals may become open during extreme distribution conditions and render the device unsterile.
Distribution
Nationwide and VA/govt/military. No foreign consignees.
Lot / Code Info
Lot W1605101: Exp 2016-12 Lot W1605103: Exp 2016-11 Lot W1605106: Exp 2016-11 Lot W1606063: Exp 2016-12 Lot W1605101: Exp 2016-12 W1605103: 2016-11 W1605106: 2016-11 W1606063: 2016-12
Root Cause
Packaging
Action Taken
Consignees notified on August 12, 2016 via letter to identify and return product.
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