Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk
Angiodynamics Inc. is recalling 50 boxes of Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the recall as FDA Class II and cites unsafe levels of bacterial endotoxins, which aligns with the rubric criteria for Severe severity involving significant health risks.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 50 boxes of Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818. 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 numbers involved are 5303175 and 5305572, with UPN H965458180.
This recall is classified as Class II by the FDA. Consumers and healthcare providers should check their inventory for these specific catalog and lot numbers and stop using the products if they match the recalled items.
The recalled product
- Product
- Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, Catalog Number 45-818
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Hazard
- Affected units
- 50
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 (3)
- UPN: H965458180
- Lot: 5303175
- 5305572
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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