Arrow PICC Catheter Recall Due to Incorrect Component Kits
Arrow International is recalling specific PICC catheter kits because they may contain the wrong catheter size or lumen configuration, potentially delaying patient treatment.
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. The hazard is a component mismatch that may delay treatment, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Arrow International Inc is recalling 2,691 units of ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC) kits. The affected product codes are PR-35041-HPHNM and CDA-35041-HPK1A. The recall covers kits distributed nationwide in the United States with lot numbers 13F16A0089, 13F16A0180, 13F17B0290, and 23F16F0614.
The recall was initiated because finished good kits may contain incorrect components. Specifically, kits intended to contain a 5 FR 2 lumen catheter may instead contain a 4 FR single lumen catheter, and vice versa. This discrepancy may cause a delay in treatment while a replacement catheter is obtained.
Healthcare facilities and consumers should check their inventory for the specific lot numbers and product codes listed above. If the affected kits are found, they should be removed from use and returned to Arrow International Inc according to the company's instructions.
The recalled product
- Product
- ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Affected units
- 2,691
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 (4)
- Lot/Batch Numbers: 13F16A0089
- 13F16A0180
- 13F17B0290
- 23F16F0614.
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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