Reported Sep 25, 2013 · Terminated
Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the…
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. d.b.a. Integra Pain Management · 3498 West 2400 South #1050 · Salt Lake City, UT · 84119
Is this the product you have?
- 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.
- Lot codes and dates
- INSHITH Lots
W1205183W1207036W1209165W1209166W1209168W1210156W1210157W1210158W1210159W1210160W1211021W1211030W1211135W1211136W1211137
- W1212170 INSHITHND LotsW1210230
- INSHITHRZN Lots
W1209156W1211182W1212090W1212125W1212178W1301258W1302005W1302031W1303148
- INSHITH Lots
- Amount recalled
- 8,648
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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