Angiodynamics Recalls BioFlo PICC Kits Due to Bacterial Endotoxins
Angiodynamics Inc. is recalling BioFlo PICC nursing kits because a component 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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the potential for significant injury from unsafe levels of bacterial endotoxins in a medical device.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 132 boxes of BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019. The recall was initiated 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 5301073 and 5304893, and the Universal Product Number (UPN) is H965750191.
Healthcare providers and consumers should check their inventory for the specific catalog number and lot numbers listed above. 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
- BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG, Catalog Number 75-019
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Line
- Hazard
- Affected units
- 132
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: H965750191
- Lot: 5301073
- 5304893
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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