Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in AMS kits are recalled because splits or holes may 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 is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) kits. The recall is due to the possibility that the gloves may contain splits or holes, which could compromise their sterility.
The affected product is the Extremity Pack (1344), part number AMS6561, manufactured by Windstone Medical Packaging, Inc. The specific lot number is 101250, with an expiration date of 10/8/2019. A total of 60 kits were distributed to locations 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.
Healthcare facilities and consumers who have these specific gloves should stop using them and contact the recalling firm, Windstone Medical Packaging, Inc., for further instructions or a replacement.
The recalled product
- Product
- Extremity Pack (1344), part number AMS6561
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- 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 number and expiration date 101250
- 10/8/2019
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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