Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk
Angiodynamics Inc. is recalling 298 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.
What this means for you
Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or those with hospitalization reports, are rated as Severe (4). While specific injury reports are not detailed in the provided text, the presence of unsafe bacterial endotoxins in a medical device constitutes a significant health risk warranting a Severe rating under the Class II criteria.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 298 boxes of Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895. The recall was initiated because a component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
The affected products were distributed to 34 US states and the District of Columbia, as well as to Canada, China, Ireland, and Spain. The specific lot number is 5304321 and the Universal Product Number (UPN) is H965458950.
Healthcare providers and patients should stop using the affected kits and contact the manufacturer for further instructions or a replacement.
The recalled product
- Product
- Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG, Catalog Number 45-895
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 298
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 (2)
- UPN: H965458950
- Lot: 5304321
Distribution
Part of a larger recall action
This product is one of 38 recalled by Angiodynamics Inc. (Navilyst Medical 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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