The Recall Desk
HighFDA (Devices)·Z-1366-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in Aligned Medical Solutions kits are recalled because splits or holes may 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 involves a risk of harm (compromised sterility) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) kits. The recall is being conducted because the gloves may contain splits or holes that could compromise sterility.

The affected product is the Set Up Pack, part number PSS3574(A. A total of 820 kits are involved in this recall. The 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.

Healthcare facilities and consumers should stop using these specific gloves and contact the recalling firm for further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product
Set Up Pack, part number PSS3574(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
820

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 (20)

  • Lot number and expiration date 100490
  • 8/7/2019 84969
  • 5/27/2018 85341
  • 6/15/2018 85566
  • 6/8/2018 86926
  • 8/2/2018 86927
  • 7/16/2018 87263
  • 10/10/2018 89647
  • 11/23/2018 89913
  • 10/2/2018 94889
  • 11/28/2018 95156
  • 11/14/2018 95674
  • 12/27/2018 96088
  • 1/25/2019 96849
  • 3/7/2019 96990
  • 5/7/2019 97637
  • 5/27/2019 98073
  • 5/23/2019 98373
  • 5/30/2019 99444
  • 6/24/2019

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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