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, and the presence of unsafe levels of bacterial endotoxins in a medical device poses a significant risk of harm, meeting the criteria for a Severe rating.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 81 boxes of BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kits with 70cm Nitinol Wire PG, Catalog Number 75-033. 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 territories, including Arizona, California, and New York, as well as to Canada, China, Ireland, and Spain. The specific lot numbers involved are 5310029 and 5310762, and the Universal Product Number (UPN) is H965750335.
Healthcare facilities and consumers should check their inventory for these specific catalog numbers and lot numbers. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG, Catalog Number 75-033
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Line Kit
- Affected units
- 81
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: H965750335
- Lot: 5310029
- 5310762
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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