Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES are being recalled because they may contain 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 is classified as FDA Class II. The hazard involves a risk of harm (compromised sterility) in a medical device, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
The U.S. Food and Drug Administration has issued a recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140. These gloves are components of the Basic Extended Pack, kit part number AMS4421, which are convenience custom kits used for general surgery in hospital operating rooms.
The recall was initiated because the gloves may contain splits or holes that compromise sterility. The affected lot number is 79640 with an expiration date of 1/10/2018. The recall involves 20 kits.
The product was distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. Windstone Medical Packaging, Inc. is the recalling firm. Hospitals and healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Basic Extended Pack, kit part number AMS4421. convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 20
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 (1)
- Lot Number/Expiration Date: 79640 1/10/2018
Distribution
Part of a larger recall action
This product is one of 150 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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