Medical Device Spine Pack Light Handles May Separate During Surgical Use
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.
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 recall for surgical equipment where handle covers may separate during use, potentially compromising sterile field and patient safety. Classified as a risk-of-harm device defect without documented injuries.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Aligned Medical Solutions Spine Pack kits (Reference AMS4599(C), containing P 2 Cover Light Handle Blue STE, Sterile EO). This recall affects 30 kits distributed in Massachusetts.
The light handle covers on these surgical packs may separate or detach from the light handle during procedure use. If a cover detaches, it could delay the surgical procedure and compromise the sterile field, potentially resulting in injury to the patient.
The affected lot numbers are 187143 and 188654. The product's UDI (Unique Device Identifier) is B098AMS4599C0. This is an FDA Class II recall.
The recalled product
- Product
- Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- component-separation
- sterile-field-compromise
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 187143 and 188654
- UDI: B098AMS4599C0
Distribution
Distributed in 1 state:
- MA
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