Windstone Medical Breast Augmentation Kits Recalled for Sterility Compromise
Windstone Medical Packaging is recalling breast augmentation kits because the disposable gloves included 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 gloves) 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 1,498 Breast Augmentation Packs, including kit part numbers AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. These convenience custom kits are used for general surgery in hospital operating rooms. The recall is due to the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES (Part # 13140) included in the custom AMS kit, which may contain splits or holes that compromise sterility.
The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall covers specific lot numbers and expiration dates ranging from October 2013 to November 2016.
Healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for instructions on returning or disposing of the product. Patients who have already had surgery using these kits should contact their healthcare provider if they have concerns about potential sterility issues.
The recalled product
- Product
- Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,498
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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