The Recall Desk
HighFDA (Devices)·Z-0230-2017·Announced 2016-10-26

Medtronic Disposable Gloves Recalled for Potential Sterility Compromise

Windstone Medical Packaging is recalling 20 Major Breast Packs containing Medtronic gloves that may have splits or holes, compromising 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 sterility is compromised, posing a risk of infection (risk-of-harm product), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 20 Major Breast Packs (Kit number AMS3409) used for general surgery in hospital operating rooms. The recall is due to the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES (Part # 13140) included in the custom kits, which may contain splits or holes that compromise sterility.

The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The specific lot numbers and expiration dates involved are 71660 (8/3/2016) and 73216 (8/17/2016).

Hospitals and surgical facilities should stop using these specific kits and contact Windstone Medical Packaging for instructions on returning or disposing of the affected inventory.

The recalled product

Product
Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
20

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 (1)

  • Lot Numbers/Expiration Dates: 71660 8/3/2016 73216 8/17/2016

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 150 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 150 products in this recall →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · sterility compromise

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