Windstone Medical Recalls Custom Surgical Kits Due to Sterile Barrier Breach
Windstone Medical Packaging is recalling 60 custom surgical kits containing a recalled catheter component due to a potential sterile barrier breach.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential sterile barrier breach, which poses a risk of infection and falls under the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling 60 kits of the AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO. The recall is being conducted because the kits were manufactured with part #63310 Catheter Urethral 10FR 16", which was previously recalled by CR Bard for a potential sterile barrier breach.
The affected products were distributed in the state of South Carolina. The specific lot number for the recalled kits is 109138.
Healthcare facilities and consumers who have these specific kits should stop using them and contact Windstone Medical Packaging, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
- Manufacturer
- Windstone Medical Packaging, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 60
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot # 109138
Distribution
Distributed in 1 state:
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