The Recall Desk
HighFDA (Devices)·Z-1327-2017·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

The U.S. Food and Drug Administration is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES that are part of custom Aligned Medical Solutions (AMS) kits. The recall is due to the possibility that the gloves may contain splits or holes, which could compromise their sterility.

The affected product is the Lap Minor Pack (1346), part number AMS6566, manufactured by Windstone Medical Packaging, Inc. The specific lot number is 101255 with an expiration date of 10/8/2019. 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.

Healthcare facilities and consumers should check their inventory for this specific lot number and expiration date. If found, the gloves should be removed from use and returned to the supplier or recalled firm as directed.

The recalled product

Product
Lap Minor Pack (1346), part number AMS6566
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard

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 101255
  • 10/8/2019

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.

See all →

Same hazard · sterility compromise

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