The Recall Desk
HighFDA (Devices)·Z-1338-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom 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 medical device where a defect (splits/holes) compromises sterility, posing a risk of infection or harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 85 Major Kits (part number PHC1307(A)) that contain Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES. The recall is due to the possibility that the gloves may contain splits or holes, which could compromise sterility.

The affected 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. Specific lot numbers and expiration dates are listed in the agency's recall record.

Consumers and healthcare facilities should stop using the affected gloves and contact Windstone Medical Packaging or their supplier for instructions on return or replacement.

The recalled product

Product
Major Kit, part number PHC1307(A
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical/Procedural Kits
Hazard
Affected units
85

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 84334
  • 6/8/2018 86584
  • 8/7/2018 89801
  • 1/24/2019 96122
  • 3/6/2019 97375
  • 6/2/2019 98632
  • 6/3/2019

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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