BioFlo PICC Nursing Kit Recalled for Unsafe Bacterial Endotoxin Levels
Angiodynamics Inc. is recalling BioFlo PICC Nursing Kits because a component 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the presence of unsafe levels of bacterial endotoxins in a medical device constitutes a significant health risk, meeting the criteria for a Severe rating.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 3 boxes of BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kits with 70cm Nitinol Wire PG, Catalog Number 75-032. 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, including Arizona, California, and New York, as well as to Canada, China, Ireland, and Spain. The specific lot number for the recalled items is 5312035, and the Universal Product Number (UPN) is H965750325.
Healthcare facilities and consumers who have these specific kits should stop using them and contact the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- BioFlo PICC (NV) 5FSL-55cm Maximal Barrier Nursing Kit w/ 70cm Nitinol Wire PG, Catalog Number 75-032
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Line Kit
- Affected units
- 3
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: H965750325
- Lot: 5312035
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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