Reported Sep 14, 2016 · Terminated
Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. d.b.a. Integra Pain Management · 3498 W 2400 S Ste 1050 · Salt Lake City, UT · 84119-1135
Is this the product you have?
- Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
- Lot codes and dates
- Lot W1605101Exp 2016-12
- Lot W1605103Exp 2016-11
- Lot W1605106Exp 2016-11
- Lot W1606063Exp 2016-12
- Lot W1605101Exp 2016-12
- W16051032016-11
- W16051062016-11
- W16060632016-12
- Amount recalled
- 710
Where it was sold
- Nationwide
- VA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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