Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins
Angiodynamics Inc. is recalling 7 boxes of RS 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 recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric for medical devices with potential for temporary or medically reversible health consequences.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 7 boxes of RS 5F DL BIOFLO PASV kits, Catalog Number 60M150373. 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 and the District of Columbia, as well as to Canada, China, Ireland, and Spain. The specific lot number is 5303174 and the Universal Product Number (UPN) is H96560M1503731.
Healthcare facilities and consumers should stop using the affected kits and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- RS 5F DL BIOFLO PASV, Catalog Number 60M150373
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Hazard
- Affected units
- 7
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: H96560M1503731
- Lot: 5303174
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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