Integra Cranial Access Kits Recalled Due to Potential Sterility Compromise
Integra LifeSciences is recalling Cranial Access Kits because product seals may open during distribution, rendering the devices unsterile.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (loss of sterility in a surgical kit) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Integra LifeSciences Corp. d.b.a. Integra Pain Management is recalling Integra Cranial Access Kits (Catalogue Nos. INSHITH, INSHITHRZN, INSHITHND). The recall involves 710 units distributed nationwide and to VA/government/military facilities. No foreign consignees are listed.
The recall was initiated after Integra LifeSciences was notified by Adaptive Surgical, LLC regarding Riverlon Nylon 3-0 Sutures packaged within the kits. It was determined that product seals may become open during extreme distribution conditions. This failure can render the device unsterile.
Affected lots include W1605101 (Exp 2016-12), W1605103 (Exp 2016-11), W1605106 (Exp 2016-11), and W1606063 (Exp 2016-12). Healthcare providers and facilities should stop using these kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Integra Cranial Access Kits, Catalogue Nos. INSHITH; INSHITHRZN; INSHITHND
- Category
- Medical Device — Surgical Kits
- Affected units
- 710
Distribution
Distributed nationwide across the United States.
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