Angiodynamics Recalls PICC Catheters Due to Stylet Diameter Labeling Error
Angiodynamics Inc. is recalling specific PICC catheters because the stylet diameter may differ from the label, potentially causing stiffening.
What this means for you
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 stylet diameter that may lead to stiffening, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling Peripherally Inserted Central Catheters (PICC) and associated Maximal Barrier Nursing Kits. The recall involves 48 cartons of the product, specifically Lot # 4941411, which were distributed nationwide to California, Florida, Georgia, Hawaii, Louisiana, Michigan, Minnesota, Missouri, Nevada, Ohio, and Texas.
The recall was initiated due to a labeling discrepancy regarding the stylet component. 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 discrepancy creates a potential for stylet stiffening that is not accurately represented on the labeling.
Healthcare facilities and consumers who have received these specific PICC catheters should stop using them and contact the manufacturer for instructions on return or replacement. The affected products are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection of contrast media.
The recalled product
- Product
- Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 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 Technolo
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Catheters
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 #: 4941411
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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