Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins
Angiodynamics Inc. is recalling 104 boxes of RS 5F DL BIOFLO PASV 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 agency classification is FDA Class II, and the presence of unsafe levels of bacterial endotoxins in a medical device poses a significant risk of adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 104 boxes of RS 5F DL BIOFLO PASV kits, Catalog Number 60M183481. The recall is being conducted because a component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
The affected products were distributed to 33 US states, including Arizona, California, and Texas, as well as to Canada, China, Ireland, and Spain. The specific lot numbers involved are 5301023, 5310193, and 5312020.
Healthcare providers and consumers should stop using the affected kits and contact the recalling firm for further instructions.
The recalled product
- Product
- RS 5F DL BIOFLO PASV, Catalog Number 60M183481
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Hazard
- Affected units
- 104
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 (4)
- UPN: H96560M1834811
- Lot: 5301023
- 5310193
- 5312020
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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