The Recall Desk
HighFDA (Devices)·Z-1308-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Sterility Compromise in Surgery Kits

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) without reported illnesses or injuries in the source text, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The U.S. Food and Drug Administration has issued a recall for Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. These gloves are part of custom Aligned Medical Solutions (AMS) kits, specifically the General Surgery Pack (part number PSS1380(A). The recall is being conducted by Windstone Medical Packaging, Inc.

The recall was initiated because the gloves may contain splits or holes that compromise sterility. This defect poses a risk of infection if the compromised sterile barrier is used during surgical 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. The recall involves 80 kits with specific lot numbers and expiration dates ranging from May 2018 to August 2019. Healthcare facilities and consumers should stop using these products and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
General Surgery Pack, part number PSS1380(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
80

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 (5)

  • Lot number and expiration date 84680
  • 5/19/2018 85462
  • 8/6/2018 86849
  • 8/16/2018 87483
  • 8/11/2019

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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