Windstone Medical Recalls Ortho Pack Kits Due to Sterility Concerns
Windstone Medical Packaging is recalling 92 Ortho Pack kits because they may contain defective gloves with 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-harm product (sterile surgical gloves) where injury has not yet been reported, fitting the High severity criteria for potential sterility compromise without confirmed illness.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 92 Ortho Pack kits, specifically kit numbers PSS3466 and PSS3466(A). These are convenience custom kits used for general surgery in hospital operating rooms. The recall is limited to specific lot numbers and expiration dates: 74829 (5/25/2017), 78510 (8/8/2017), 79116 (11/5/2017), and 79279 (1/18/2018).
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 compromise the sterility of the gloves, which is a critical safety requirement for surgical instruments and supplies.
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 check their inventory for these specific lot numbers and expiration dates and stop using the affected kits immediately.
The recalled product
- Product
- Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 92
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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