Arrow PICC Recall for Incorrect Length Labeling
Arrow International Inc. is recalling Arrow PICC kits because some may contain a different length than labeled.
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 device length. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving potential misuse or incorrect application.
Plain-English summary
Arrow International Inc. is recalling Arrow PICC powered by Arrow VPS Precision Stylet kits (Product Code: CDC-45052-VPS2) due to labeling errors. The recall involves 963 units distributed nationwide in the United States.
The hazard is that kits labeled as containing a 40 cm PICC may actually contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC. This discrepancy could lead to the use of an incorrect device length for the intended medical procedure.
Healthcare providers and consumers should stop using the affected lots (23F18F0005, 23F18B0583) and contact Arrow International Inc. for further instructions or a replacement.
The recalled product
- Product
- Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 963
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 (2)
- Lot /Batch Number: 23F18F0005
- 23F18B0583 GTN:40801902120753
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Arrow International 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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