Windstone Medical Recalls Dr. Landi EVLT Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 2,048 Dr. Landi EVLT 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 (glove splits/holes) compromises sterility, creating a risk of harm in a high-risk setting (surgery), but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 2,048 units of the Dr. Landi EVLT Pack, a convenience custom kit used for general surgery in hospital operating rooms. The recall is limited to specific kit numbers (AMS1483(A, AMS1483(B, and AMS1483(C) and associated lot numbers and expiration dates ranging from 2014 to 2017.
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 could compromise the sterility of the gloves, posing a risk to patients during surgical procedures.
The affected kits were distributed nationwide to hospitals 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 Windstone Medical Packaging for instructions on return or disposal.
The recalled product
- Product
- Dr. Landi EVLT Pack, Kit numbers AMS1483(A, AMS1483(B, and AMS1483(C convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 2,048
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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