The Recall Desk
HighFDA (Devices)·Z-0212-2017·Announced 2016-10-26

Windstone Medical Knee Packs Recalled for Potential Sterility Compromise

Windstone Medical is recalling 30 Knee Packs because the included Medtronic gloves may contain 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 risk-of-harm product (sterile surgical gloves) where injury has not yet been reported, fitting the 'High' severity criteria for potential sterility compromise.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 30 units of the Knee Pack, Kit number AMS4211. These are convenience custom kits used for general surgery in hospital operating rooms. The recall is due to a defect in the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in the custom AMS kit.

The gloves may contain splits or holes that compromise sterility. The affected lot number is 77332 with an expiration date of 8/10/2017. The products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Hospitals and surgical facilities should stop using these specific kits and contact Windstone Medical Packaging for instructions on return or disposal. No illnesses or injuries have been reported in the source text.

The recalled product

Product
Knee Pack, Kit number AMS4211 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Supplies
Hazard
Affected units
30

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 Number/ Expiration Date: 77332 8/10/2017

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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