Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
The FDA is recalling Medtronic disposable gloves used in Lap Band kits because splits or holes may 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 gloves) where injury has not yet been reported, fitting the High severity criteria for potential sterility compromise.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in the custom AMS1785(A) Lap Band Pack kits. The recall was initiated because the gloves may contain splits or holes that could compromise their sterility.
The affected kits were distributed nationwide to hospitals in California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall involves 390 kits with various lot numbers and expiration dates ranging from October 2014 to August 2016.
Healthcare facilities should stop using the affected gloves and contact the recalling firm, Windstone Medical Packaging, Inc., for further instructions. Consumers are not directly affected as these are professional medical devices used in hospital operating rooms.
The recalled product
- Product
- Lap Band Pack, Kit number AMS1785(A convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Hazard
- Affected units
- 390
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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