Windstone Medical Recalls Surgical Kits Due to Potential Sterility Compromise
Windstone Medical Packaging is recalling 360 Minor/General/Ortho Packs because Medtronic gloves inside may have 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 kits) where injury has not yet been reported, fitting the 'High' severity criteria for potential sterility compromise.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 360 units of the Minor/General/Ortho Pack (Kit numbers PSS3258, PSS3258(A, and PSS3258(B). 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) 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. Specific lot numbers and expiration dates for the affected units are listed in the agency's recall record.
Hospitals and healthcare facilities should stop using these kits and contact Windstone Medical Packaging for instructions on return or replacement. Patients who have had surgery using these kits should consult their healthcare provider if they have concerns about infection or other complications.
The recalled product
- Product
- Minor/General/Ortho Pack, Kit number PSS3258, PSS3258(A, and PSS3258(B 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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