Windstone Medical Packaging Recalls Plastic Surgery Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 120 Plastic Surgery Packs because the disposable gloves included may have 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 is classified as FDA Class II. The hazard involves compromised sterility in medical devices, which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 120 units of the Plastic Surgery Pack, part number AMS5685. The recall is due to a potential defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits. The gloves may contain splits or holes that could compromise sterility.
The affected 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. The recall covers two specific lots: Lot 100266 with an expiration date of 9/8/2019, and Lot 100267 with an expiration date of 9/21/2019.
Healthcare facilities and consumers who have these specific kits should stop using them and contact Windstone Medical Packaging, Inc. for further instructions or a replacement.
The recalled product
- Product
- Plastic Surgery Pack, part number AMS5685
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 120
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 (3)
- Lot number and expiration date 100266
- 9/8/2019 100267
- 9/21/2019
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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