The Recall Desk
HighFDA (Devices)·Z-0211-2017·Announced 2016-10-26

Windstone Medical Knee Arthroscopy Kits Recalled for Sterility Compromise

Windstone Medical Packaging is recalling knee arthroscopy kits 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 is classified as FDA Class II. The hazard involves a risk-of-harm product (sterile surgical kits) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling specific knee arthroscopy convenience custom kits used for general surgery in hospital operating rooms. The affected kits include the AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A models.

The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, included in these custom kits may contain splits or holes. These defects can compromise the sterility of the medical devices, posing a risk to patients during surgical procedures.

The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. Various lot numbers and expiration dates are involved, ranging from January 2014 to January 2018. Healthcare facilities should check their inventory for these specific lot numbers and stop using the affected kits immediately.

The recalled product

Product
Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard

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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