The Recall Desk
HighFDA (Devices)·Z-1337-2017·Announced 2017-03-08

Medtronic Disposable Gloves Recalled for Sterility Compromise in AMS Kits

Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES in custom 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 involves a medical device where a defect (splits/holes) compromises sterility, creating a risk of infection or harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

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 their sterility.

The affected product is the Major Breast Pack, part number AMS3409(B. A total of 40 kits were distributed to locations 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.

Consumers and healthcare facilities should stop using these gloves and contact the recalling firm for instructions on return or replacement. The specific lot numbers and expiration dates for the affected units are 95427 (6/7/2017), 9551 (6/12/2017), 95604 (6/2/2017), 96600 (10/23/2017), and 99890 (10/21/2017).

The recalled product

Product
Major Breast Pack, part number AMS3409(B
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Gloves
Hazard
Affected units
40

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 (6)

  • Lot number and expiration date 95427
  • 6/7/2017 9551
  • 6/12/2017 95604
  • 6/2/2017 96600
  • 10/23/2017 99890
  • 10/21/2017

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.

See all →

Same hazard · sterility compromise

See all →