Windstone Medical recalls Aligned Medical Solutions Minor Hand Pack REF AMS6539E due to risk of light handle cover detaching during use, potentially causing procedure delays or patient injury.
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
Windstone Medical is recalling Aligned Medical Solutions Minor Hand Packs with reference number AMS653:9E because the light handle cover might detach during use. This could delay medical procedures or cause patient injuries by compromising the sterile field.
The light handle cover may detach and fall off during use. This could delay medical procedures and compromise the sterile field, potentially leading to patient injuries.
Healthcare professionals using this hand pack during medical procedures are most at risk. Patients undergoing surgery or procedures with this device could be affected if the cover detaches.
Check for the product reference number AMS6539E on the packaging. The lot numbers 187154 and 189008 are associated with this recall.
Verify the product reference number AMS6539E and lot numbers 187154 or 189008 on the packaging.
Aligned Medical Solutions Minor Hand Pack with reference number AMS6539E, containing a P 2 Cover Light Handle Blue STE, Sterile EO.
The cover may detach during use, causing procedure delays or compromising the sterile field, which could lead to patient injuries.
Look for the product reference number AMS6539E and lot numbers 187154 or 189008 on the packaging.
We’ve drafted a message you can send Windstone Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1620-2023 — Windstone Medical Windstone Medical Hello, I own a Windstone Medical that is covered by recall Z-1620-2023 from Windstone Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
