Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions 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 (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) kits. The recall is being conducted because the gloves may contain splits or holes that could compromise sterility.
The affected product is the Ocular Plastic Pack, part number AMS3868(A, with a quantity of 100 kits. The specific lots involved are 86489 (expiration 8/9/2017), 88198 (expiration 8/29/2017), 88412 (expiration 8/20/2017), and 88868 (expiration 12/25/2017).
These 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. Consumers and healthcare facilities should check their inventory for these specific lot numbers and expiration dates and stop using the affected gloves if found.
The recalled product
- Product
- Ocular Plastic Pack, part number AMS3868(A
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 100
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 (5)
- Lot number and expiration date 86489
- 8/9/2017 88198
- 8/29/2017 88412
- 8/20/2017 88868
- 12/25/2017
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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