The Recall Desk
HighFDA (Devices)·Z-1300-2017·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 involves a medical device where sterility is compromised, posing a risk of infection or harm, but the source text does not report any specific injuries or illnesses, 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 being conducted because the gloves may contain splits or holes that could compromise their sterility.

The affected product is identified by lot number 101262 and an expiration date of 5/9/2018. The recall involves 24 kits. These products 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.

Consumers and healthcare facilities should stop using the affected gloves and contact Windstone Medical Packaging, Inc. for further instructions or a replacement.

The recalled product

Product
Facial Pack , part number AMS6501
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
24

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 (2)

  • Lot number and expiration date 101262
  • 5/9/2018

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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