Medtronic Disposable Gloves Recalled for Potential Sterility Compromise
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES because splits or holes may compromise sterility. The gloves are part of custom surgical kits.
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 sterility compromise in surgical gloves, which is a high-risk hazard for infection, but no specific illnesses or injuries have been reported in the source text.
Plain-English summary
Medtronic is recalling COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, which are included in custom kits. The recall was initiated because the gloves may contain splits or holes that could compromise sterility.
The affected gloves are part of the Abdominoplasty Tray custom kits manufactured by Windstone Medical Packaging, Inc. These kits are used for general surgery in hospital operating rooms. The recall involves 192 kits distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Healthcare facilities should stop using the affected gloves and contact the manufacturer for instructions on return or replacement. Patients who have had procedures using these kits should consult their healthcare provider if they have concerns about infection or sterility.
The recalled product
- Product
- Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Gloves
- Affected units
- 192
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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