Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling Bio-Stable 5F kits 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 58 boxes of Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886. 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 5303442 and the UPN is H965458860.
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
- Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-886
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Hazard
- Affected units
- 58
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: H965458860
- Lot: 5303442
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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