The Recall Desk
HighFDA (Devices)·Z-1259-2017·Announced 2017-03-08

Medtronic Gloves in AMS Kits Recalled for Sterility Compromise

Windstone Medical Packaging is recalling 174 Angio Pack kits because the Medtronic gloves inside may have splits or holes that 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, creating a risk of harm (infection) without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 174 units of the Angio Pack, part number AMS6711. These custom Aligned Medical Solutions (AMS) kits 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 the sterility of the product.

The affected lots have the following numbers and expiration dates: 100927 (7/18/2019), 100928 (8/30/2019), and 101484 (9/23/2019). 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 kits and contact Windstone Medical Packaging, Inc. for further instructions on return or replacement.

The recalled product

Product
Angio Pack, part number AMS6711
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
174

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 (4)

  • Lot numbers and Expiration dates: 100927
  • 7/18/2019 100928
  • 8/30/2019 101484
  • 9/23/2019

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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