Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
Recall
- Recall Number
- Z-0984-2024
- Event Number
- 93733
- Firm
- Steris Corporation
- FEI Number
- 1527821
- Product Code
- HBM
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- December 12, 2023
- Posted
- February 5, 2024
- Address
- 5960 Heisley Rd, Mentor, OH, 44060-1834
Description
Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
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.
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).
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.
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