Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a compromise of sterility in a medical device, which poses a significant risk of infection or injury.
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 the sterility of the product.
The affected product is the Lap/Pelviscopy Pack, part number PSS3256(B, manufactured by Windstone Medical Packaging, Inc. A total of 168 kits are involved in this recall. The affected lots include 85327, 88019, 88577, 89638, 95231, 95423, 96080, and 99559, with expiration dates ranging from July 14, 2018, to June 5, 2019.
The product was 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 the affected gloves and contact the recalling firm for further instructions.
The recalled product
- Product
- Lap/Pelviscopy Pack, part number PSS3256(B
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 168
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 (9)
- Lot number and expiration date 85327
- 7/14/2018 88019
- 9/5/2018 88577
- 12/27/2018 89638
- 1/29/2019 95231
- 1/12/2019 95423
- 1/2/2019 96080
- 6/21/2019 99559
- 6/5/2019
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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