—#205327

Product

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

FDA product code: HBM — Headrest, Neurosurgical
Device class: Class 1
Medical specialty: Neurology
Affected lot / code info: UDI-DI: 00724995195885, date of manufacture 2023-08-14 thru 2023-10-26.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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).

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

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.

Timeline

Recall initiated: 2023-12-12
Posted by FDA: 2024-02-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205327. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.