Windstone Medical Recalls Surgical Procedure Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 666 Dr. Newman Surgical Procedure Packs because the Medtronic gloves inside 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. The hazard involves compromised sterility in a surgical setting, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 666 units of the Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 and PSS1689(A). These are convenience custom kits used for general surgery in hospital operating rooms.
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 and the kit.
The affected kits were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall covers 19 specific lot numbers with expiration dates ranging from July 10, 2015, to June 27, 2017. Hospitals and medical facilities should stop using these kits and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Dr. Newman Surgical Procedure Pack, kit numbers PSS1689 PSS1689(A convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 666
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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