Windstone Medical Abdominoplasty Kits Recalled for Sterility Compromise
Windstone Medical Packaging is recalling 45 Abdominoplasty Kits because the included Medtronic gloves may contain splits or holes that compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device where a defect (glove splits/holes) compromises sterility, creating a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 45 Abdominoplasty Packs (part numbers AMS3326(B, AMS4381, and AMS4381(B)). 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 for the affected units include 80483 (1/19/2017), 86796 (2/26/2018), 88290 (2/7/2017), 89931 (1/15/2018), 98043 (9/7/2018), and 98446 (4/2/2019).
Healthcare facilities and consumers should check their inventory for these specific part numbers and lot dates. If the product is found, it should be removed from use and returned to the supplier or the manufacturer for credit or replacement, as per standard recall procedures.
The recalled product
- Product
- Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 45
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 numbers and Expiration dates: 80483
- 1/19/2017 86796
- 2/26/2018 88290
- 2/7/2017 89931
- 1/15/2018 98043
- 9/7/2018 98446
- 4/2/2019
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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