Windstone Medical Recalls Extremity Packs Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 810 Extremity Packs because the disposable gloves inside may contain splits or holes that compromise sterility.
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: The recall involves a medical device where sterility is compromised, which is a risk-of-harm product. The source text does not report any illnesses or injuries, fitting the criteria for a High severity score (risk-of-harm products where injury has not yet been reported).
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 810 units of Extremity Packs. The affected products include various part numbers such as AMS3240, AMS4764, AMS4788(A, PSS1798(A, PSS1842(A, and PSS2706. These kits were distributed in Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, Ohio, Pennsylvania, Texas, Utah, Virginia, and Washington.
The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits may contain splits or holes. These defects could compromise the sterility of the gloves, posing a risk to patient safety during medical procedures.
Healthcare facilities and consumers who have these specific Extremity Packs should stop using them immediately. The source text does not provide specific instructions for disposal or return, but users should contact their supplier or the manufacturer for further guidance on how to handle the affected units.
The recalled product
- Product
- Extremity Pack, part number AMS3240 Extremity Pack, part number AMS4764 Extremity Pack, part number AMS4788(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1798(A Extremity Pack, part number PSS1842(A Extremity…
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 810
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 (20)
- Lot number and expiration date 100226
- 9/11/2019 101400
- 10/7/2019 84373
- 5/28/2018 84678
- 6/8/2018 84896
- 5/26/2018 84959
- 7/29/2018 85470
- 2/23/2017 85505
- 7/23/2018 85547
- 8/23/2018 85695
- 7/8/2018 85846
- 8/5/2018 86258
- 9/19/2018 86509
- 9/28/2018 86663
- 8/11/2019 86686
- 9/9/2018 86908
- 9/13/2018 87155
- 9/16/2018 87730
- 7/5/2017 87968
- 9/6/2018 88008
Distribution
Part of a larger recall action
This product is one of 124 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.
See all 124 products in this recall →Related recalls
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