Cranial Access — Class II medical device recall Z-2260-2013
Terminated recall by Integra LifeSciences Corp. d.b.a. Integra Pain Management, reported 2013-09-25, distributed nationwide. Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the st
| Recall number | Z-2260-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT, United States |
| Recall initiated | 2013-09-04 |
| Classified | 2013-09-19 |
| Reported by FDA | 2013-09-25 |
| Terminated | 2014-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 8,648 |
| Reason classes | sterility, packaging |
| Lot numbers | W1205183, W1207036, W1209156, W1209165, W1209166, W1209168, W1210156, W1210157, W1210158, W1210159, W1210160, W1210230, W1211021, W1211030, W1211135, W1211136, W1211137, W1211182, W1212090, W1212125, W1212170, W1212178, W1301258, W1302005, W1302031, W1303148 |
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 patients to reduce intracranial pressure (ICP), to monitor CSF, to provide temporary drainage of CSF, and to monitor ICP.
Reason for recall
Integra is recalling certain lots of Cranial Access Kit due to a possibility that the seal integrity of the sterile package may become compromised during shipping.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2260-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.