The Recall Desk
HighFDA (Devices)·Z-1289-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom 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 the hazard involves a risk of harm (compromised sterility) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. These gloves are part of custom Aligned Medical Solutions (AMS) kits, specifically the D&C/Cysto Pack (part number PSS3257(D). The recall was initiated because the gloves may contain splits or holes that could compromise their sterility.

The affected 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. The recall involves 380 kits with various lot numbers and expiration dates ranging from 2017 to 2019.

Healthcare facilities and consumers should stop using the affected gloves immediately. Users should contact the recalling firm, Windstone Medical Packaging, Inc., for further instructions on how to return or dispose of the products.

The recalled product

Product
D&C/Cysto Pack, part number PSS3257(D
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
380

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 (11)

  • Lot number and expiration date 100086
  • 5/12/2019 85563
  • 8/13/2017 87345
  • 8/18/2017 89066
  • 8/8/2017 94998
  • 8/18/2017 95508
  • 8/12/2017 95667
  • 3/10/2017 96490
  • 8/5/2017 97900
  • 4/13/2019 99440
  • 4/5/2019

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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