Reported May 10, 2023 · Ongoing
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including…
Steris Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834
Is this the product you have?
- Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control
- REFLB53
- Lot codes and dates
- GTIN number00724995150136
- Lot Numbers9604187 / 9604187A 9604188 / 9604188A 9604189 / 9604189A 9604190 / 9604190A 9604191 / 9604191A 9799082 / 9799082A 9799083 / 9799083A 9799084 / 9799084A 9799085 / 9799085A 9799086 / 9799086A 9799087 / 9799087A 9799088 / 9799088A 9799089 / 9799089A 9799090 / 9799090A 9799091 / 9799091A 9799092 / 9799092A 9799093 / 9799093A 9799094 / 9799094A 9799095 / 9799095A 9799096 / 9799096A 9799097 / 9799097A 9799098 / 9799098A 9799099 / 9799099A 9799100 / 9799100A 9799101 / 9799101A 9799102 / 9799102A 9799103 / 9799103A 9799104 / 9799104A 9799105 / 9799105A 9799106 / 9799106A 9799107 / 9799107A 9799108 / 9799108A
- Amount recalled
- 1,358,520 covers
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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