Windstone Medical Recalls Minor Arthroscopy Packs Due to Sterility Concerns
Windstone Medical Packaging is recalling 356 Minor Arthroscopy Packs because disposable gloves in the kits may contain splits or holes that compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 surgical gloves, which poses a risk of infection (risk-of-harm product), but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 356 units of Minor Arthroscopy Packs, specifically Kit numbers 002649-14 and 002649-15. 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 that compromise sterility.
The affected products were distributed nationwide to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming. The recall covers specific lot numbers with expiration dates ranging from August 13, 2013, to July 2, 2016.
Healthcare facilities should stop using the affected kits and contact Windstone Medical Packaging for further instructions on returning or disposing of the products.
The recalled product
- Product
- Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 356
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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