The Recall Desk
HighFDA (Devices)·Z-1264-2017·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 is classified as FDA Class II, and the hazard involves a risk of harm (infection due to compromised sterility) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. These gloves are part of custom Aligned Medical Solutions (AMS) kits, specifically the Basic Extended Pack (part numbers AMS4421(A and AMS4421(B)). The recall was initiated by Windstone Medical Packaging, Inc.

The reason for the recall is that the gloves may contain splits or holes, which could compromise their sterility. This defect poses a risk of infection if the non-sterile gloves are used in sterile medical procedures. 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.

Healthcare providers and facilities should stop using these gloves immediately. Users should check their inventory for the specific part numbers and lot numbers listed in the official recall notice. If the gloves are found, they should be quarantined and returned to the supplier or manufacturer for credit or replacement, following the instructions provided by Windstone Medical Packaging, Inc.

The recalled product

Product
Basic Extended Pack, part number AMS4421(A Basic Extended Pack, part number AMS4421(B
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
170

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 (7)

  • Lot number and expiration date 84855
  • 8/6/2018 88319
  • 9/5/2018 88950
  • 11/15/2018 95760
  • 1/26/2019 96235
  • 5/14/2019 98080
  • 6/19/2019

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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