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U.S. Department of Health and Human Services

Class 2 Device Recall NATUS CRANIAL ACCESS KIT

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  Class 2 Device Recall NATUS CRANIAL ACCESS KIT see related information
Date Initiated by Firm November 18, 2022
Date Posted December 20, 2022
Recall Status1 Open3, Classified
Recall Number Z-0735-2023
Recall Event ID 91193
Product Classification Intracranial pressure & temperature monitoring kit - Product Code PSP
Product 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).
Code Information 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
Recalling Firm/
Manufacturer		 Natus Medical Incorporated
5955 Pacific Center Blvd
San Diego CA 92121-4309
For Additional Information Contact Technical Service Team
858-455-1115
Manufacturer 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.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action 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
Quantity in Commerce 249 kits
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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