Reported May 31, 2023 · Ongoing
Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Windstone Medical Packaging, Inc.
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: Windstone Medical Packaging, Inc. · 1602 4th Ave N · Billings, MT · 59101-1521
Is this the product you have?
- Aligned Medical Solutions Hand Pack
- REF
AmS4601Econtaining P 2 Cover Light Handle Blue STESterile EO
- Lot codes and dates
- Lot 188843
- UDIB098AMS4601E0
- Amount recalled
- 60 kits
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
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.
Want the full recall guide?
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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