Xcela PICC catheter mislabeled with incorrect size designation
Angiodynamics is recalling Xcela PICC catheters where units labeled as 5F are actually 4F. The labeling discrepancy between labeled and actual product size could affect clinical device selection.
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 Class II labeling error where the catheter size designation does not match the actual product specifications. No injuries or illnesses have been reported. The mislabeling of a medical device specification falls under the criterion of minor labeling errors.
Plain-English summary
Angiodynamics Inc. is recalling certain lots of Xcela PICC with PASV Valve Technology/Kit due to a labeling discrepancy. The affected units are labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) but the actual product is 4F (55cm; Maximum Flow Rate 3.5 mL/Sec). This means the labeled catheter size does not match the size of the product actually supplied.
The Xcela PICC is 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 recall affects Lot Number 5210162 (UDI: H96560M7019951), which was distributed in Canada. Healthcare providers should verify that their inventory matches actual product specifications.
The recalled product
- Product
- Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the…
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — PICC Catheter
- 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 Number: 5210162 (UDI): H96560M7019951
Distribution
Distribution scope not specified by the agency.
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