Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling Opgrande Hand Packs containing Medtronic gloves due to potential splits or holes that 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 involves a medical device where sterility may be compromised, posing a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 48 kits of the Opgrande Hand Pack, part number AMS4767. These kits contain Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. The recall is being conducted because the gloves may contain splits or holes that could compromise sterility.
The affected product is identified by lot number 84376 and an expiration date of 5/25/2018. The kits 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 Windstone Medical Packaging for further instructions or a return.
The recalled product
- Product
- Opgrande Hand Pack, part number AMS4767
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 48
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 84376
- 5/25/2018
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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