Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk
Angiodynamics Inc. is recalling 20 boxes of Bio-Stable 5F kits because a component may contain unsafe levels of bacterial endotoxins.
What this means for you
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 potential contamination hazard (bacterial endotoxins) that poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 20 boxes of Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872. The recall is issued 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 5304983 and the Universal Product Number (UPN) is H965458720.
Healthcare facilities and consumers 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 disposed of according to local regulations.
The recalled product
- Product
- Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved PG, Catalog Number 45-872
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Affected units
- 20
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: H965458720
- Lot: 5304983
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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