The Recall Desk
HighFDA (Devices)·Z-1273-2017·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 (sterility compromise) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that were 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 Bayview Abdominoplasty Pack, part number 009079-1. A total of 35 kits 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 specific lot numbers and expiration dates for the recalled items are 87231 (4/19/2018), 87645 (4/11/2018), and 89152 (4/4/2018). Users should check their inventory for these specific lot numbers and stop using the product if it matches the description.

The recalled product

Product
Bayview Abdominoplasty Pack, part number 009079-1
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
35

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 (4)

  • Lot number and expiration date 87231
  • 4/19/2018 87645
  • 4/11/2018 89152
  • 4/4/2018

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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