Windstone Medical Mammoplasty Kits Recalled for Potential Sterility Compromise
Windstone Medical Packaging is recalling 140 Mammoplasty Kits 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 kit) 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 140 Mammoplasty Packs, Kit number AMS2535. 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 have expiration dates ranging from March 2014 to May 2016. The kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
Hospitals and surgical facilities should stop using the affected kits and contact Windstone Medical Packaging for instructions on return or disposal. Patients who have already had surgery using these kits should contact their healthcare provider if they have concerns about infection or other complications.
The recalled product
- Product
- Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 140
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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