Z-0984-2024 Class II Ongoing

Recalled by Steris Corporation — Mentor, OH

Recall Details

Product Type
Devices
Report Date
February 14, 2024
Initiation Date
December 12, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
80

Product Description

Dual Articulating Headrest, Velcro P/N P141210813, REF BF753

Reason for Recall

Dual-articulating head rest may not stay in place or may fail to lock into position during a patient procedure which could result in an injury to the patient or a procedural delay.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of AZ, CA, FL, IL, IN, IA, KS, LA, MN, MS, NV, NJ, OH, OK, OR, PA, TN, TX, UT, WA, WI & Puerto Rico, and the countries of Australia, Canada, Mexico & New Zealand.

Code Information

UDI-DI: 00724995195885, date of manufacture 2023-08-14 thru 2023-10-26.