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) where injury has not yet been reported, fitting the criteria for a High severity score.
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 was initiated because the gloves may contain splits or holes that could compromise sterility.
The affected product is the Universal Pack, part number AMS2036, manufactured by Windstone Medical Packaging, Inc. A total of 15 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.
The specific lot numbers and expiration dates for the recalled items are 87597 (expiring 2/28/2017) and 88967 (expiring 4/30/2017). Consumers and healthcare facilities should stop using these gloves and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Universal Pack, part number AMS2036
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 15
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 (3)
- Lot number and expiration date 87597
- 2/28/2017 88967
- 4/30/2017
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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