Medtronic Disposable Gloves Recalled for Sterility Compromise in Arthroscopy Kits
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions arthroscopy 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. The hazard involves a breach of sterility in a medical device used for surgery, which carries a significant risk of serious injury or infection, fitting the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) arthroscopy kits. The recall involves 60 kits, specifically the Arthroscopy Pack with part number AMS6559. The affected lot number is 101247, with an expiration date of 10/9/2019.
The gloves are being recalled because they may contain splits or holes that compromise sterility. This defect poses a risk of infection or other adverse health consequences if the non-sterile gloves are used in a sterile surgical environment.
The affected products 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 who have these specific kits should stop using them and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Arthroscopy Pack, part number AMS6559
- 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 101247
- 10/9/2019
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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