Windstone Medical Packaging Recalls Augmentation Packs with Defective Gloves
Windstone Medical Packaging is recalling 60 Augmentation Packs because the disposable gloves may contain splits or holes that 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 involves a medical device where a defect (splits or holes) compromises sterility, posing a risk of harm, but the source text does not report any specific illnesses or injuries.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 60 kits of the Augmentation Pack, part number AMS6370. The recall involves the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits.
The recall was initiated because the gloves may contain splits or holes that compromise sterility. The affected lot number is 101499, with an expiration date of 10/13/2019.
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. Consumers and healthcare facilities should stop using the affected products and contact the manufacturer for instructions.
The recalled product
- Product
- Augmentation Pack, part number AMS6370
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 60
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 101499
- 10/13/2019
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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