The Recall Desk
HighFDA (Devices)·Z-1374-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom kits are being 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 product (sterility compromise) 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 was initiated because the gloves may contain splits or holes that could compromise sterility.

The affected product is identified as the Total Joint Pack, part number 006358-6, manufactured by Windstone Medical Packaging, Inc. A total of 14 kits were distributed across 27 states, including 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 associated with the recall include 84847 (2/28/2017), 87391 (3/31/2017), 89385 (6/17/2017), 89960 (6/8/2017), 94833 (6/26/2017), and 97859 (6/23/2017). Healthcare facilities and consumers should stop using these gloves and contact the recalling firm for further instructions.

The recalled product

Product
Total Joint Pack, part number 006358-6
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
14

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 number and expiration date 84847
  • 2/28/2017 87391
  • 3/31/2017 89385
  • 6/17/2017 89960
  • 6/8/2017 94833
  • 6/26/2017 97859
  • 6/23/2017

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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