Angiodynamics Recalls PICC Catheters Due to Stylet Diameter Labeling Error
Angiodynamics is recalling PICC catheters because the stylet diameter may be larger than stated on the label.
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: The recall is classified as FDA Class II, and the hazard involves a labeling error regarding the stylet diameter. As no injuries or illnesses are reported in the source text, this fits the Moderate criteria for minor labeling errors or low-risk issues.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling Peripherally Inserted Central Catheters (PICC) and associated Maximal Barrier Nursing Kits. The recall involves 50 cartons of the product, which were distributed nationwide to California, Florida, Georgia, Hawaii, Louisiana, Michigan, Minnesota, Missouri, Nevada, Ohio, and Texas.
The recall is due to a labeling discrepancy regarding the stylet included with the catheter. The product label states that the stylet has an outside diameter (OD) of 0.014, but the product may actually contain a stylet with an OD of 0.016. This potential for stylet stiffening is not accurately represented on the current labeling.
Healthcare facilities and consumers who have these specific PICC catheters should stop using them and contact the manufacturer for instructions on return or replacement. The affected lot number is 4945781.
The recalled product
- Product
- Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve…
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Catheters
- Hazard
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)
- Lot #: 4945781
Distribution
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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