The Recall Desk
HighFDA (Devices)·Z-1360-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom 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 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 is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) kits. The recall is due to the possibility that the gloves may contain splits or holes, which could compromise their sterility.

The affected product is identified as a Plastic Kit with part number CMP1084(C. The recall involves 580 kits distributed across 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 are listed in the agency's records.

Healthcare facilities and consumers who have these specific kits should stop using the gloves and contact the manufacturer or the FDA for further instructions on how to return or dispose of the product.

The recalled product

Product
Plastic Kit, part number CMP1084(C
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
580

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 (14)

  • Lot number and expiration date 86626
  • 9/3/2017 87202
  • 9/16/2017 87481
  • 9/9/2017 87924
  • 9/17/2017 88217
  • 10/31/2017 88819
  • 10/27/2017 89271
  • 10/11/2017 89539
  • 12/7/2017 95831
  • 1/9/2018 96460
  • 4/12/2018 98055
  • 6/30/2018 98962
  • 6/22/2018 99088
  • 9/15/2018

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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