The Recall Desk
HighFDA (Devices)·Z-0285-2017·Announced 2016-10-26

Windstone Medical Recalls Dr. Fritsch Surgical Kits Due to Sterility Concerns

Windstone Medical Packaging is recalling 224 Dr. Fritsch surgical kits because the included Medtronic gloves 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 (glove splits/holes) compromises sterility, posing a risk of harm (infection) even though no specific injuries are reported in the text, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling 224 units of the Dr. Fritsch Pack, Kit number AMS2696. 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 lots are 63188 (expiration 1/4/2015), 63187 (expiration 1/28/2015), 63186 (expiration 1/29/2015), and 65285 (expiration 6/7/2015). The products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

Hospitals and healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for instructions on return or disposal. The FDA has classified this as a Class II recall.

The recalled product

Product
Dr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
224

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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