Windstone Medical Custom Surgery Kits Recalled for Sterility Compromise
Windstone Medical Packaging recalled 56 custom surgery kits because the included Medtronic gloves may contain splits or holes, compromising 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 harm without confirmed illness.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 56 units of Custom Tray kits (Kit numbers PSS1836 and PSS1836A) 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. The gloves may contain splits or holes, which compromises the sterility of the kit.
The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The specific lot numbers and expiration dates for the recalled units are 59060 (11/3/2015), 57225 (5/21/2016), 57696 (7/9/2016), 72681 (1/11/2017), and 77152 (7/13/2017).
Healthcare facilities should stop using these kits and contact Windstone Medical Packaging for instructions on return or disposal. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Custom Tray, Kit numbers: PSS1836 and PSS1836(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
- 56
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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