The Natus Cranial Access Kit is designed to be a complete, single use and disposable accessory and instrumentation set t

FDA device recall Z-0735-2023 · posted 2022-12-20 · Open, Classified

Recall details

Recalling firm

Natus Medical Incorporated

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.

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

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

PSP

Quantity affected

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.

Date initiated

2022-11-18

Date posted

2022-12-20

Location

San Diego, CA