Moderate FDA (Devices)·Z-2260-2013·Announced 2013-09-25

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.

What this means for you

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 patient
Manufacturer: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Category: Medical Device — Neurological / Cranial
Hazard: sterility-compromise
packaging-defect
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

Distributed nationwide across the United States.

The notice also names 14 states specifically:

Same manufacturer · Integra LifeSciences Corp. d.b.a. Integra Pain Management

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