Windstone C-Section Kits Recalled Due to Potential Glove Splits or Holes
Windstone Medical Packaging is recalling C-Section kits because the included Medtronic gloves may have 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 sterility compromise in surgical gloves, which is a high-risk hazard for infection, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 268 C-Section Pack kits, including kit numbers 002643-10, 002643-9, and AMS4449 convenience custom kits. These 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 kits, 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 with expiration dates ranging from August 31, 2013, to February 15, 2018.
Hospitals and healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for further instructions. Consumers are not directly affected as these products are intended for professional medical use in operating rooms.
The recalled product
- Product
- C-Section Pack, Kit number 002643-10, 002643-9, and AMS4449 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 268
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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