Reported Dec 28, 2022 · Ongoing
The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set…
Natus Medical Incorporated
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: Natus Medical Incorporated · 5955 Pacific Center Blvd · San Diego, CA · 92121-4309
Is this the product you have?
- 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 the kit are comprised to make it convenient for the practitioner to have all that they need in one place for fast and efficient intracranial access. cerebral spinal fluid (CSF).
- Lot codes and dates
- Part NumberHITH1
- UDI-DI Code382830048590
- Lot Number22GDB675
- Part NumberHITHNDRZR
- UDI-DI Code382830048620
- Lot Number22HDA557
- Part NumberHITHLT
- UDI-DI Code382830048637
- Lot Number22IDB724
- Amount recalled
- 249 kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Natus Medical Incorporated recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.