Windstone Medical Extremity Kits Recalled for Potential Sterility Compromise
Windstone Medical is recalling 3,829 Extremity 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 kits) 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 3,829 units of Extremity Packs, including kit numbers AMS2726, AMS2937, AMS3240, PSS1381(A, PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706. 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) included in the custom AMS kit, which may contain splits or holes that compromise sterility.
The affected products 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 May 26, 2014, to February 25, 2018.
Hospitals and healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for instructions on returning or disposing of the products. Consumers are not directly affected as these are professional medical devices used in hospital settings.
The recalled product
- Product
- Extremity Pack, Kit number AMS2726, AMS2937, AMS3240, PSS1381(A PSS1381(B, PSS1798(A, PSS1842(A, and PSS2706 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 3,829
Distribution
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.
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