Integra Recalls Cranial Access Kits Due to Labeling Discrepancies
Integra LifeSciences is voluntarily recalling unexpired lots of HITHSP10 Cranial Access Kits because the labeling for included DuraPrep and Monocryl sutures does not align with the kit's intended use.
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 involves minor labeling errors regarding component alignment, which fits the rubric for moderate severity involving labeling issues without reported injuries.
Plain-English summary
Integra LifeSciences Corp. d.b.a. Integra Pain Management is voluntarily recalling unexpired lots of the HITHSP10 Cranial Access Kit. The recall is due to identified labeling discrepancies where the labeling for the DuraPrep and Monocryl sutures included in the kit does not align with the intended use and labeling of the Cranial Access Kit itself.
The affected product is the Integra Cranial Access Kit, Model Number HITHSP10, which is intended for burr hole access to the subarachnoid space or lateral ventricles of the brain to reduce intracranial pressure, monitor CSF, and provide temporary drainage. The recall covers 731 units distributed nationwide.
The specific lots affected are W1302120 (Expires 2/1/2014), W1305038 (Expires 8/1/2015), and W1306137 (Expires 9/1/2014). Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected kits.
The recalled product
- Product
- Integra Cranial Access Kit, Model Number HITHSP10, Rx Only. Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is intended to be used with an external drainage and monitoring system in…
- Hazard
- Affected units
- 731
Distribution
Distributed nationwide across the United States.
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