The Recall Desk
HighFDA (Devices)·Z-1307-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in AMS 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 involves a risk-of-harm product (sterile gloves) where injury has not yet been reported, fitting the 'High' severity criteria for potential compromise of sterility.

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 General Plastics Pack, part number 008617-1. A total of 465 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.

Healthcare facilities and consumers should stop using the affected gloves and contact Windstone Medical Packaging, Inc. for instructions on returning the product or obtaining a replacement.

The recalled product

Product
General Plastics Pack, part number 008617-1
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
465

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 (13)

  • Lot number and expiration date 85096
  • 12/11/2017 85458
  • 12/20/2017 88364
  • 12/27/2017 89172
  • 9/3/2018 95260
  • 9/20/2018 95790
  • 9/9/2018 96288
  • 9/18/2018 96562
  • 9/20/2018 97526
  • 9/27/2018 97560
  • 9/13/2018 99232
  • 2/1/2019 99232
  • 2/1/2019

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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