The Recall Desk
HighFDA (Devices)·Z-1371-2017·Announced 2017-03-08

Medtronic Cover Light Handle Gloves Recalled for Sterility Compromise

Medtronic Cover Light Handle Disposable Gloves in 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 is classified as FDA Class II, and the hazard involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Medtronic Cover Light Handle Disposable Gloves. These gloves are part of custom Aligned Medical Solutions (AMS) kits, specifically the Stem Pack with part number AMS5166. The recall was initiated by Windstone Medical Packaging, Inc.

The recall is due to the possibility that the gloves may contain splits or holes, which could compromise the sterility of the product. This defect poses a risk to patient safety by potentially allowing contamination.

The affected product was 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 96521, with an expiration date of January 31, 2018. A total of 16 kits are involved in this recall.

Healthcare facilities and consumers should stop using the affected gloves immediately and contact the recalling firm for further instructions or a return.

The recalled product

Product
Stem Pack, part number AMS5166
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
16

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 96521
  • 1/31/2018

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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