The Recall Desk
HighFDA (Devices)·Z-1314-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria.

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 Head/Neck Pack, part number AMS6121. The recall involves 24 kits with lot number 100105 and an expiration date of 6/21/2019. These 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.

Consumers and healthcare facilities should stop using the affected gloves and contact the recalling firm for instructions on return or replacement.

The recalled product

Product
Head/Neck Pack, part number AMS6121
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical/Procedural Supplies
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 100105
  • 6/21/2019

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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