Arrow PICC Recall for Incorrect Length Labeling
Arrow International is recalling 963 Arrow PICC kits because some are labeled with the wrong length, potentially leading to incorrect clinical use.
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, which is a moderate severity level. The hazard is a labeling error regarding device length, which is a significant clinical issue but does not involve a high-risk pathogen or immediate life-threatening defect like a structural failure.
Plain-English summary
Arrow International Inc is recalling 963 units of Arrow PICC powered by Arrow VPS Precision Stylet (Product Code: CDC-44052-VPS2) distributed nationwide in the United States. The recall is due to a labeling error where 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.
The affected product is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and central venous pressure monitoring. The specific lot number is 23F18B0581 and the GTIN is 20801902120704.
Healthcare providers and facilities should check their inventory for this specific product code and lot number. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. Patients who have already received the device should consult their healthcare provider if they have concerns regarding the device length.
The recalled product
- Product
- Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-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
- Hazard
- 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 (1)
- Lot/Batch Number: 23F18B0581 GTIN:20801902120704
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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