Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits are recalled because splits or holes may compromise sterility.
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: The recall is classified as FDA Class II. The hazard involves compromised sterility in medical gloves, which poses a risk of infection, but the source text does not report any specific illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration is recalling 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 identified as the GYN Lap Pack, part number PSS2194(B, manufactured by Windstone Medical Packaging, Inc. The specific lot number is 97553 with an expiration date of 4/25/2018. A total of 5 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.
Healthcare facilities and consumers should stop using these gloves immediately. Users should contact the recalling firm, Windstone Medical Packaging, Inc., for further instructions on how to return or dispose of the affected product.
The recalled product
- Product
- GYN Lap Pack, part number PSS2194(B
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 5
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 97553
- 4/25/2018
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.
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