Windstone Medical Recalls Vascular Packs Due to Sterility Compromise
Windstone Medical Packaging is recalling 360 Vascular 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. The hazard involves compromised sterility in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 360 units of Vascular Pack, part number AMS4030. These kits are custom Aligned Medical Solutions (AMS) kits that include Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES.
The recall was initiated because the gloves included in the kits may contain splits or holes. These defects could compromise the sterility of the medical supplies.
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. Specific lot numbers and expiration dates are listed in the official recall record. Healthcare facilities and consumers should stop using these products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Vascular Pack, part number AMS4030 Vascular Pack, part number AMS4030(A
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 360
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 (7)
- Lot number and expiration date 89251
- 12/25/2018 89524
- 10/25/2018 89601
- 12/17/2018 89838
- 12/17/2018 99349
- 6/18/2019 99729
- 10/7/2019
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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