The Recall Desk
HighFDA (Devices)·Z-1258-2017·Announced 2017-03-08

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.

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 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
Hazard
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

Distributed in 26 states:

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 →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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