Windstone Medical Recalls Minor Lithotomy Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 114 Minor Lithotomy 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 is classified as FDA Class II, and the hazard involves compromised sterility in a surgical setting, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 114 units of the Minor Lithotomy Pack, Kit number 002650-7. These are convenience custom kits used for general surgery in hospital operating rooms. The recall is limited to specific lot numbers and expiration dates ranging from 2014 to 2016.
The recall was initiated because the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, included in the custom AMS kit may contain splits or holes. These defects can compromise the sterility of the surgical environment.
The affected kits were distributed nationwide to facilities in California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. Healthcare facilities should stop using the affected kits and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Minor Lithotomy Pack, Kit number 002650-7 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 114
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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