Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES Recalled for Sterility Compromise
Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may 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 risk-of-harm product (sterile gloves) where injury has not yet been reported, fitting the High severity criteria for potential compromise of sterility without confirmed illness.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that were part of custom Aligned Medical Solutions (AMS) kits. The recall is due to the possibility that the gloves contain splits or holes, which could compromise sterility.
The affected product is identified as the Brow Pack, part number PSS1785(C. The recall involves 36 kits. Specific lot numbers and expiration dates include 85694 (9/29/2018), 88886 (11/18/2018), and 89480 (12/11/2018).
The product was 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. Users should stop using the affected gloves and contact the recalling firm for instructions.
The recalled product
- Product
- Brow Pack, part number PSS1785(C
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 36
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 number and expiration date 85694
- 9/29/2018 88886
- 11/18/2018 89480
- 12/11/2018
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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