Windstone Medical Packaging, Inc.: 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

Agency Publication Date: May 23, 2023

Affected Products

Product: Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO

Lot #s 187143 and 188654; UDI: B098AMS4599C0

Product: Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO

Lot #s 187154 and 189008, UDI: B098AMS6539E0

Product: Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

Lot 188843; UDI: B098AMS4601E0

Lot Numbers:

188843

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92288

Status: Active

Manufacturer: Windstone Medical Packaging, Inc.

Manufactured In: United States

Units Affected: 3 products (30 kits; 90 kits; 60 kits)

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Sources: FDA iRES · Raw API Response

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