The Recall Desk
HighFDA (Devices)·Z-0242-2017·Announced 2016-10-26

Windstone Medical Recalls Minor Surgery Kits Due to Sterility Concerns

Windstone Medical Packaging is recalling 1,025 minor surgery kits because the Medtronic gloves included 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 risk-of-harm product (sterile surgical kit) 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 1,025 units of Minor Pack convenience custom kits (styles AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A). These kits are 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) included in the custom AMS kit, 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 recall covers specific lot numbers with expiration dates ranging from April 4, 2015, to February 27, 2018.

Hospitals and healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for further instructions. Consumers are not directly affected as these products are intended for professional medical use.

The recalled product

Product
Minor Pack AMS1374(A, CMP1560, PSS3517, PSS3517(A, PSS3518, PSS3518(A, PSS3541, and PSS3541(A. convenience custom kits used for general surgery in hospital operating room
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
1,025

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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