The Recall Desk
HighFDA (Devices)·Z-1351-2017·Announced 2017-03-08

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES Recalled for Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom Aligned Medical Solutions kits are being 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 gloves) 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 sterility.

The affected product is the Open Procedure Pack II, part number RMS1740(A, manufactured by Windstone Medical Packaging, Inc. A total of 160 kits are involved in this recall. The 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 stop using the affected gloves and contact the recalling firm for instructions on return or replacement. The specific lot numbers and expiration dates associated with this recall include 84814 (2/6/2018), 86168 (8/30/2018), 88510 (12/1/2018), 89151 (1/21/2019), 95032 (1/13/2019), 96555 (6/1/2019), 98134 (6/6/2019), and 99502 (9/17/2019).

The recalled product

Product
Open Procedure Pack II, part number RMS1740(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
160

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 (9)

  • Lot number and expiration date 84814
  • 2/6/2018 86168
  • 8/30/2018 88510
  • 12/1/2018 89151
  • 1/21/2019 95032
  • 1/13/2019 96555
  • 6/1/2019 98134
  • 6/6/2019 99502
  • 9/17/2019

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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