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

FDA Recall #Z-0983-2024 — Class II — December 12, 2023

Recall #Z-0983-2024 Date: December 12, 2023 Classification: Class II Status: Ongoing

Product Description

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

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.

Recalling Firm

Steris Corporation — Mentor, OH

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

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 & New Zealand.

Code Information

UDI-DI: 00724995197643, date of manufacture 2023-08-14 thru 2023-10-26.

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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