The Recall Desk
HighFDA (Devices)·Z-1381-2017·Announced 2017-03-08

Medtronic Gloves in Custom Kits 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 is classified as FDA Class II. The hazard involves a risk of harm (compromised sterility) without reported illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Windstone Medical Packaging, Inc. 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 Vein Tray, part number AMS6312. The recall involves 60 kits with lot number 101265 and an expiration date of 11/1/2018. These 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.

Healthcare facilities and consumers should stop using the affected gloves and contact Windstone Medical Packaging, Inc. for further instructions or a return.

The recalled product

Product
Vein Tray, part number AMS6312
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical/Procedural Supplies
Hazard
Affected units
60

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 101265
  • 11/1/2018

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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