Angiodynamics Recalls TANDEM 5F DL BIOFLO PASV Kits Due to Endotoxins
Angiodynamics Inc. is recalling TANDEM 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 is classified as FDA Class II, and the hazard involves unsafe levels of bacterial endotoxins in a medical device, which poses a risk of harm without reported fatalities or hospitalizations.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling the TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567. The recall is being issued 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 5316349, and the Universal Product Number (UPN) is H96560M1405671.
Healthcare providers and facilities should check their inventory for this specific catalog number and lot. If the product is found, it should be removed from use and returned to the manufacturer or the distributor from which it was purchased.
The recalled product
- Product
- TANDEM 5F DL BIOFLO PASV, Catalog Number 60M140567
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 1
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: H96560M1405671
- Lot: 5316349
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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