FDA (Devices) recall action 92288
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Windstone Medical Packaging is recalling Aligned Medical Solutions Hand Pack kits because light handle covers may detach during surgical procedures, potentially compromising the sterile field.
Windstone Medical Packaging recalls the Aligned Medical Solutions Minor Hand Pack because light handle covers may detach during procedures. This could delay surgery and compromise the sterile field, risking patient injury.
Windstone Medical Packaging recalls Aligned Medical Solutions Spine Pack kits due to light handle covers that may separate during surgery. This could delay procedures and compromise the sterile field, potentially injuring patients.