Angiodynamics Recalls RS Tandem 5F DL Bioflo Pasv Catheters
Angiodynamics Inc. is recalling RS Tandem 5F DL Bioflo Pasv catheters because components 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 from bacterial endotoxins, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 2 boxes of RS Tandem 5F DL Bioflo Pasv catheters, Catalog Number 60M120196. The recall is due to the possibility that 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 5314930 and the Universal Product Number (UPN) is H96560M1201961.
Healthcare providers and consumers should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- RS TANDEM 5F DL BIOFLO PASV, Catalog Number 60M120196
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Catheter
- 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: H96560M1201961
- Lot: 5314930
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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