Angiodynamics Recalls RS 5F DL BIOFLO PASV Kits Due to Endotoxins
Angiodynamics Inc. is recalling 2 boxes of RS 5F DL BIOFLO PASV kits because a component may contain unsafe levels of bacterial endotoxins.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (unsafe levels of bacterial endotoxins) where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 2 boxes of RS 5F DL BIOFLO PASV kits, Catalog Number 60M161567. 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 34 US states and the District of Columbia, as well as to Canada, China, Ireland, and Spain. The specific lot number is 5316086 and the UPN is H96560M1615671.
Healthcare providers and consumers should stop using the affected kits and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- RS 5F DL BIOFLO PASV, Catalog Number 60M161567
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Hazard
- Affected units
- 2
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: H96560M1615671
- Lot: 5316086
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.
See all 38 products in this recall →Related recalls
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