Windstone Medical Knee Scope Packs Recalled for Sterility Compromise
Windstone Medical Packaging is recalling 156 Knee Scope 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 involves a risk-of-harm product (sterile medical device) where the hazard is a potential breach of sterility, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 156 Knee Scope Packs, part numbers AMS2498(A, AMS2498(B, and AMS2498(C. The recall involves specific lots with expiration dates ranging from May 2018 to January 2019.
The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in the custom Aligned Medical Solutions (AMS) kits may contain splits or holes. These defects could compromise the sterility of the medical device.
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. Healthcare facilities and consumers should stop using these specific kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Knee Scope Pack, part number AMS2498(A Knee Scope Pack, part number AMS2498(B Knee Scope Pack, part number AMS2498(C
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 156
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 (9)
- Lot number and expiration date 84341
- 5/27/2018 85494
- 7/21/2018 86719
- 9/2/2018 86872
- 8/19/2018 87445
- 8/2/2018 88048
- 11/22/2018 89163
- 11/19/2018 94930
- 1/5/2019
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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