Integra Recalls Cranial Access Kits Due to Potential Sterile Seal Compromise
Integra LifeSciences is recalling specific lots of Cranial Access Kits because the sterile package seal may become compromised during shipping.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a potential loss of sterile integrity during shipping. No illnesses or injuries are reported in the source text, and the risk is described as a possibility rather than a confirmed defect, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Integra LifeSciences Corp. d.b.a. Integra Pain Management is recalling specific lots of Cranial Access (CRAK) Kits. The affected product catalog numbers are INSHITH, INSHITHND, and INSHITHRZN. These kits are intended to be used with an external drainage and monitoring system to access the subarachnoid space or lateral ventricles of the brain, reduce intracranial pressure, monitor cerebrospinal fluid, and provide temporary drainage.
The recall is being conducted due to a possibility that the seal integrity of the sterile package may become compromised during shipping. A compromised sterile seal could potentially affect the sterility of the device.
A total of 8,648 units were distributed nationwide, including in California, Colorado, Florida, Indiana, Kansas, North Carolina, Nevada, New York, Oklahoma, Tennessee, Texas, Virginia, Washington, and Wisconsin. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected…
- Affected units
- 8,648
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- INSHITH Lots: W1205183
- W1207036
- W1209165
- W1209166
- W1209168
- W1210156
- W1210157
- W1210158
- W1210159
- W1210160
- W1211021
- W1211030
- W1211135
- W1211136
- W1211137
- W1212170 INSHITHND Lots: W1210230 INSHITHRZN Lots: W1209156
- W1211182
- W1212090
- W1212125
- W1212178
Distribution
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