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Dual Articulating Headrest, Velcro P/N P141210813, REF BF753 recallZ-0984-2024 · Steris Corporation · initiated Dec 12, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

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).

Recall details

Recall number
Z-0984-2024
Status
Open, Classified
Initiated by the company
Dec 12, 2023
Posted by the FDA
Feb 5, 2024
Recalling firm
Steris Corporation
Quantity
80
Product code
HBM
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.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93733).

Sources and updates

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