Windstone Medical Recalls Bayview Breast Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling Bayview Breast Packs because disposable gloves in the kits 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 medical device where a defect (glove splits/holes) compromises sterility, creating a risk of infection or harm in a surgical setting. No specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 312 Bayview Breast Packs, Kit part numbers 009080-1 and 009080-2. These convenience custom kits are used for general surgery in hospital operating rooms. The recall is being conducted because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, included in the custom AMS kit, may contain splits or holes that compromise sterility.
The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall covers specific lot numbers with expiration dates ranging from October 25, 2014, to January 17, 2017.
Hospitals and healthcare facilities should check their inventory for the affected lot numbers and stop using these kits. Users should contact Windstone Medical Packaging for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Bayview Breast Pack, Kit part numbers 009080-1 and 009080-2 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 312
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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