FDAFDA · Food and drugs·Recall number Z-0984-2024
Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
Published February 14, 2024 · Recall initiated: December 12, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Steris Corporation
- Distributor
- 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.
- Lot
- UDI-DI: 00724995195885, date of manufacture 2023-08-14 thru 2023-10-26.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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