Windstone Medical Packaging Recalls Lower Extremity Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 198 Lower Extremity Packs because the disposable gloves inside 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 is classified as FDA Class II and involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 198 units of the Lower Extremity Pack, part number AMS4669. The recall is due to a 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, which compromises the sterility of the product.
The affected kits 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. Specific lot numbers and expiration dates associated with the recall include AMS4669 with codes 85376, 86279, 87657, 88434, 95690, 96189, 96190, 99735, and 100446.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging, Inc. for instructions on how to return the product.
The recalled product
- Product
- Lower Extremity Pack, part number AMS4669
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 198
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 (10)
- Lot number and expiration date AMS4669
- 85376 AMS4669
- 86279 AMS4669
- 87657 AMS4669
- 88434 AMS4669
- 95690 AMS4669
- 96189 AMS4669
- 96190 AMS4669
- 99735 AMS4669
- 100446
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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