FDANovember 18, 2022device
The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set that is used to create an intracranial burr-hole typically required for procedures such as ventriculostomy or intracranial pressure (ICP) monitoring. The various components of th...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.
What to do
FDA enforcement status: Ongoing
Brands named
natus medicalnatus
UPCs
382830048590382830048620382830048637
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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