Windstone Medical Liposuction Kits Recalled for Potential Sterility Compromise
Windstone Medical Packaging recalled 35 liposuction 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 is classified as FDA Class II, and the hazard involves a risk of harm (sterility compromise) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 35 Liposuction Packs (part numbers AMS3323(B, AMS5684, and AMS5699) 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 gloves.
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. The recall covers specific lot numbers and expiration dates: 100265 (10/8/2019), 88101 (2/28/2017), and 96542 (6/15/2019).
Healthcare providers and consumers should check their inventory for these specific part numbers and lot dates. If the product is found, it should be stopped from use and returned to the supplier or the recalling firm.
The recalled product
- Product
- Liposuction Pack, part number AMS3323(B Liposuction Pack, part number AMS5684 Liposuction Pack, part number AMS5699
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 35
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 100265
- 10/8/2019 88101
- 2/28/2017 96542
- 6/15/2019
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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