Angiodynamics Recalls 5F DL BIOFLO PASV Kits Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling 36 boxes of 5F DL BIOFLO PASV kits because components 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 source text identifies the agency classification as Class II. According to the rubric, an FDA Class II recall involving a medical device with a potential for significant injury (unsafe levels of endotoxins) corresponds to a severity score of 4 (Severe), as it does not explicitly report hospitalizations or deaths to warrant a score of 5.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 36 boxes of 5F DL BIOFLO PASV kits, Catalog Number 60M141006. The recall was initiated because a component of the kits might contain unsafe levels of bacterial endotoxins, also known as pyrogens.
The affected products were distributed to 33 US states and the District of Columbia, as well as to Canada, China, Ireland, and Spain. The specific lot numbers involved are 5304286 and 5318620, and the Universal Product Number is H96560M1410061.
The FDA has classified this as a Class II recall. Healthcare providers and patients should check their inventory for these specific lot numbers and stop using the affected kits. Users should contact the manufacturer for instructions on returning or disposing of the products.
The recalled product
- Product
- 5F DL BIOFLO PASV, Catalog Number 60M141006
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 36
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 (3)
- UPN: H96560M1410061
- Lot: 5304286
- 5318620
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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