Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits are being 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 involves a risk of harm (compromised sterility) without reported illnesses or injuries, which aligns with the High severity criteria for risk-of-harm products where injury has not yet been reported.
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 was initiated because the gloves may contain splits or holes that could compromise sterility.
The affected product is the Lap Pack, part number AMS4801. The recall involves 36 kits. The specific lot numbers and expiration dates are 88798 (4/20/2017), 88994 (4/16/2017), 89895 (7/19/2017), and 97151 (7/31/2017).
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. Users should stop using the affected gloves and contact the recalling firm for further instructions.
The recalled product
- Product
- Lap Pack, part number AMS4801
- Manufacturer
- Windstone Medical Packaging, Inc.
- Hazard
- Affected units
- 36
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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