Medtronic Gloves in AMS Kits Recalled for Sterility Compromise
Windstone Medical Packaging is recalling 174 Angio Pack kits because the Medtronic gloves inside may have splits or holes that 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 involves a medical device where a defect (splits/holes) compromises sterility, creating a risk of harm (infection) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 174 units of the Angio Pack, part number AMS6711. These custom Aligned Medical Solutions (AMS) kits contain Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. 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 lots have the following numbers and expiration dates: 100927 (7/18/2019), 100928 (8/30/2019), and 101484 (9/23/2019). The 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 should stop using the affected kits and contact Windstone Medical Packaging, Inc. for further instructions on return or replacement.
The recalled product
- Product
- Angio Pack, part number AMS6711
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 174
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 (4)
- Lot numbers and Expiration dates: 100927
- 7/18/2019 100928
- 8/30/2019 101484
- 9/23/2019
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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