Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Summary
The FDA issued a Class II for Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover by Windstone Medical Packaging, Inc.. Reason: 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 ster.
Details
Source
Device Recall
External ID
Z-1620-2023
Action Date
2023-05-31
Status
Ongoing
Category
device
Product Description
Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
Lot/Code Info: Lot #s 187154 and 189008, UDI: B098AMS6539E0
Quantity Affected: 90 kits
Reason for Recall
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
Distribution
US: MA OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-24
Company
Billings, MT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 141 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Windstone Medical Packaging, Inc. has 20 FDA actions in our database, including 20 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Windstone Medical Packaging, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Windstone Medical Packaging, Inc. have FDA actions?
Windstone Medical Packaging, Inc. has 20 FDA actions in our database, including 20 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1620-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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