Aligned Medical Solutions Hand Pack covers may detach during surgical use
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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device with potential for patient injury through sterile field compromise and procedure disruption. The source text does not report any illnesses or injuries, placing this in the risk-of-harm category without documented harm.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Aligned Medical Solutions Hand Pack kits (Lot 188843, UDI: B098AMS4601E0) because the light handle covers may separate from the light handle during surgical use.
If the covers detach and fall off during a procedure, this could delay the surgery and compromise the sterile field, which could result in injury to the patient. The recalled kits consist of sterile surgical hand packs manufactured by Windstone Medical Packaging, Inc.
The recalled product was distributed to Massachusetts. Healthcare facilities and surgical centers that received this product should stop using it and contact the manufacturer for instructions on return or replacement.
Patients who underwent surgery using this product should consult their healthcare provider if they have concerns about potential infection or complications.
The recalled product
- Product
- Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Pack
- Affected units
- 60
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 188843
- UDI: B098AMS4601E0
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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