Angiodynamics Recalls Xcela Power Injectable PICCs with Incorrect Expiration Dates
Angiodynamics Inc. is recalling specific lots of Xcela Power Injectable PICCs because they are labeled with 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 Class II recall involving a labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Angiodynamics Inc. (Navilyst Medical Inc.) is recalling specific lots of Xcela Power Injectable PICCs with PASV (Cat no. 55-711). The recall is due to incorrect expiration dates on the product labels. The labeled dates extend the shelf life of the product beyond the dates supported by validation testing.
The affected product has not yet reached its validated expiry date. However, the company is removing the product to prevent its use beyond the validated expiry date. The recall involves Lot 5096448, which was distributed to accounts in Florida and to Great Britain.
The recalled product
- Product
- Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG), Cat no. 55-711
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 1
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 5096448
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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