The Recall Desk
HighFDA (Devices)·Z-1310-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom AMS 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 for potential sterility compromise.

Plain-English summary

The U.S. Food and Drug Administration has issued a recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES included in custom Aligned Medical Solutions (AMS) kits. The recall was initiated because the gloves may contain splits or holes that compromise sterility.

The affected product is the GYN Pack, part number AMS4013(A, manufactured by Windstone Medical Packaging, Inc. The recall involves 20 kits with lot number 83798 and an expiration date of 5/17/2018. 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 check their inventory for this specific lot number and expiration date. If the product is found, it should be removed from use and returned to the supplier or recalled firm as directed.

The recalled product

Product
GYN Pack, part number AMS4013(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
20

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 83798
  • 5/17/2018

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.

See all →

Same hazard · sterility compromise

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