The Recall Desk
HighFDA (Devices)·Z-1334-2017·Announced 2017-03-08

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.

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 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
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.

See all 124 products in this recall →