Summary
The FDA issued a Class II for Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754 by Steris Corporation. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0983-2024
Action Date
2024-02-14
Status
Ongoing
Category
device
Product Description
Dual Articulating Headrest, Pad Ret P/N P141210805, REF BF754
Lot/Code Info: UDI-DI: 00724995197643, date of manufacture 2023-08-14 thru 2023-10-26.
Quantity Affected: 2
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-12
Company
Mentor, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 274 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Steris Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Steris Corporation have FDA actions?
Steris Corporation has 71 FDA actions in our database, including 28 recalls and 43 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0983-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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