Windstone Medical Recalls HSG Packs Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 360 HSG Packs because the Medtronic gloves included in the kits 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 risk-of-harm product (sterile surgical gloves) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 360 units of HSG Packs, Kit number PSS3287. 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, including 67433 (8/1/2016), 71250 (9/12/2016), 69748 (9/20/2016), 71417 (1/3/2017), 72802 (4/23/2017), 74796 (7/14/2017), 78203 (8/5/2017), 76919 (8/16/2017), and 79432 (2/25/2018).
Healthcare facilities and consumers should stop using these kits immediately. The compromised sterility of the gloves poses a risk of infection during surgical procedures. Users should contact Windstone Medical Packaging for instructions on returning the affected products.
The recalled product
- Product
- HSG Pack, Kit number PSS3287 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 360
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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