Windstone Medical Recalls Lap Gallbladder Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 85 Lap Gallbladder Packs 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 risk-of-harm product (compromised sterility in surgical gloves) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 85 units of the Lap Gallbladder Pack, Kit number AMS3707. 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 76445 (expiration 8/7/2017), 79281 (expiration 8/15/2017), and 78556 (expiration 9/20/2017). 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 these kits and contact Windstone Medical Packaging for instructions on return or disposal. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Lap Gallbladder Pack, Kit number AMS3707 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 85
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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