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).
- Company
- Natus Medical Incorporated
- Recall Initiated
- November 18, 2022
- Posted
- December 20, 2022
- Recall Number
- Z-0735-2023
- Quantity
- 249 kits
- Firm Location
- San Diego, CA
Reason for Recall
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.
Distribution
U.S. Nationwide distribution in the states of AK, CA, CT, DC, FL, GA, IA, ID, IL, KS , MD, MI, MT, ND, NE, NJ, NV, NY, OH, OR, TX, and WA.
Lot / Code Info
Part Number: HITH1 UDI-DI Code: 382830048590 Lot Number: 22GDB675 Part Number: HITHNDRZR UDI-DI Code: 382830048620 Lot Number: 22HDA557 Part Number: HITHLT UDI-DI Code: 382830048637 Lot Number: 22IDB724
Root Cause
Unknown/Undetermined by firm
Action Taken
On 11/18/2022, the firm sent an "Amended Urgent Field Safety Notice - Recall" letter via first class mail to customers informing them that the 3M surgical drapes that are included in Natus Cranial Access Kits are being recalled by 3M Healthcare due to the liner on the adhesive component of the affected drapes are difficult to remove without damaging the product and may render the product unusable. In addition there is the potential for adhesive related skin injures. Customers are instructed to: 1. Complete the enclosed form, and return to FCA@Natus.com 2. Immediately cease use of the affected Cranial Access Kits that you have and quarantine until you receive the shipping instructions from Natus to return the product(s). Customers will receive shipping instructions from FCA@Natus.com For questions or further assistance contact Natus Technical Service Team via email FCA@natus.com