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, and the hazard involves a risk-of-harm product (sterile gloves) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
The U.S. Food and Drug Administration has issued a Class II recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES contained in 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 D & C Pack, part number AMS4796(A, manufactured by Windstone Medical Packaging, Inc. The specific lot number is 95176 with an expiration date of 10/20/2019. A total of 24 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.
Consumers and healthcare facilities should stop using the affected gloves immediately and contact the manufacturer or their supplier for instructions on return or replacement. Using non-sterile gloves in clinical settings poses a risk of infection or other adverse health consequences.
The recalled product
- Product
- D & C Pack, part number AMS4796(A
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 24
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 95176
- 10/20/2019
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.
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