Windstone Medical Recalls Transvaginal Packs Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 1,780 Transvaginal Packs 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 medical device where a defect (splits/holes in gloves) compromises sterility, posing a risk of infection. This fits the rubric for 'risk-of-harm products where injury has not yet been reported' (Score 3), as no specific injuries or illnesses are cited in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 1,780 units of Transvaginal Packs, Kit number CMP1767. 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 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 April 2015 to January 2018, as well as one lot with no provided date.
Hospitals and medical facilities should stop using the affected kits and contact Windstone Medical Packaging for instructions on return or disposal. Patients who have had surgery using these kits should contact their healthcare provider if they have concerns about the sterility of the equipment used.
The recalled product
- Product
- Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 1,780
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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