Aligned Medical Solutions hand pack light covers may separate during use
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving potential equipment failure during sterile surgical procedures. No hospitalizations or injuries have been reported. This is a risk-of-harm scenario where injury has not yet been documented, meeting the rubric criterion for High severity.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling the Aligned Medical Solutions Minor Hand Pack (REF: AMS6539E), a surgical kit containing light handle covers and related components. The affected lots are #187154 and #189008, with Universal Device Identifier B098AMS6539E0. Approximately 90 kits were distributed in the United States.
The light handle covers may separate or detach from the light handle during surgical use. This separation could delay the procedure and may compromise the sterile field, both of which could result in patient injury.
Healthcare facilities and surgical centers that received this product should stop using the affected lots immediately. Contact Windstone Medical Packaging, Inc. for instructions on returning the product or obtaining a replacement. The FDA recall number is Z-1620-2023.
The recalled product
- Product
- Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- component-separation
- sterile-field-compromise
- procedure-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #s 187154 and 189008
- UDI: B098AMS6539E0
Distribution
Distributed in 1 state:
- MA
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