Angiodynamics Recalls 5F DL BIOFLO PICC Kits Due to Endotoxins
Angiodynamics Inc. is recalling 5F DL BIOFLO PICC 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of significant injury from unsafe endotoxin levels in a medical device.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling 12 boxes of 5F DL BIOFLO PICC, Catalog Number 60M180592. 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 5313507, 5316369, 5318603, and 5321025, with the UPN H96560M1805921.
Healthcare providers and consumers should check their inventory for these specific catalog and lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- 5F DL BIOFLO PICC, Catalog Number 60M180592
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Line
- Hazard
- Affected units
- 12
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 (5)
- UPN: H96560M1805921
- Lot: 5313507
- 5316369
- 5318603
- 5321025
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.
See all 38 products in this recall →Related recalls
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