BioFlo PICC Recall Issued for Incorrect Expiration Date Labeling
Angiodynamics Inc. is recalling specific lots of BioFlo PICCs labeled with incorrect expiration dates that extend shelf life beyond validated testing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall for a labeling error (incorrect expiration date) with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling specific lots of BioFlo PICC with ENDEXO and PASV. The affected products are labeled with incorrect expiration dates that extend the shelf life of the product beyond the date supported by validation testing.
The recall is warranted to prevent the use of the product beyond its validated expiry date, even though the product has not yet reached that date. The affected units were distributed to accounts in Florida and to Great Britain.
Healthcare facilities and consumers should stop using the affected lots and contact the recalling firm for further instructions.
The recalled product
- Product
- BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Line
- Hazard
- Affected units
- 4
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 (1)
- 5231609
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 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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