Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754

FDA device recall Z-0983-2024 · posted 2024-02-05 · Open, Classified

Recall details

Recalling firm

Steris Corporation

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.

Action taken

An Urgent Medical Device Recall notice dated December 5, 2023 was issued to distributors and customers via FedEx explaining the removal of specific affected product . The notice explains the labeled date of manufacture must fall between August 14, 2023 and October 26, 2023 the recall notice must have been received directly from STERIS. The 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. STERIS Service Technician will work with your facility to schedule a time to hand-deliver replacement head rest(s) and pick up your affected head rest(s). It is recommended all head rests impacted by this recall be immediately removed from service until it can be replaced. If you have further distributed this product, please identify all locations, notify them of this recall, and coordinate the collection of all affected head rest(s).

Root cause

Process control

Status

Open, Classified

Product code

HBM

Quantity affected

2

Distribution

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

Date initiated

2023-12-12

Date posted

2024-02-05

Location

Mentor, OH