The Recall Desk
HighFDA (Devices)·Z-1272-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Sterility Compromise in AMS Kits

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. The hazard involves compromised sterility in medical gloves, which poses a risk of infection, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

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 due to the possibility that the gloves may contain splits or holes, which could compromise the sterility of the product.

The affected product is the Basin Pack, part number AMS2497. A total of 648 kits were distributed to facilities 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 should stop using the affected gloves and contact Windstone Medical Packaging, Inc. for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Basin Pack, part number AMS2497
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
648

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 84187
  • 5/14/2018 84938
  • 6/30/2018 85835
  • 9/12/2018 86871
  • 8/14/2019 87444
  • 9/30/2018 88377
  • 11/15/2018 88626
  • 10/8/2018 89025
  • 12/10/2018 89575
  • 1/30/2019 94929
  • 3/6/2019 96912
  • 5/5/2019 97575
  • 6/22/2019 97652
  • 9/27/2019

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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