The Recall Desk
HighFDA (Devices)·Z-1268-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Sterility Compromise in Custom Kits

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom 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 is classified as FDA Class II. The hazard involves a risk of harm (compromised sterility) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 50 kits of the Basic Pack (1185), part number AMS6560. These kits contain Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. The recall is due to the possibility that the gloves may contain splits or holes, which could compromise sterility.

The affected 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. The specific lot number is 101277, with an expiration date of 10/7/2019.

Healthcare facilities and consumers should stop using these gloves immediately. Users should check their inventory for the specific part number and lot number listed above. If found, the products should be returned to the supplier or disposed of according to local regulations to prevent the use of non-sterile medical devices.

The recalled product

Product
Basic Pack (1185), part number AMS6560
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical/Procedural Gloves
Hazard
Affected units
50

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 101277
  • 10/7/2019

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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