Arrow Pediatric Central Venous Catheter Recalled for Incorrect Labeling
Arrow International Inc. is recalling specific lots of pediatric central venous catheters because the lidstock labels list incorrect priming volumes and flow rates.
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, but the source text identifies the issue as a labeling error (incorrect priming volume and flow rates) without reporting any injuries or illnesses. This aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Arrow International Inc. is recalling 15 units of the Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402. The recall affects Lots 14F18F0336 and 14F18E0121.
The recall was initiated because the lidstock packaging states the incorrect priming volume and flow rates for the device. This is a labeling error that could potentially impact the proper use of the catheter.
The affected products were distributed nationwide in the United States, specifically to the state of Florida, as well as to Argentina, Canada, Chile, Columbia, Costa Rica, the Dominican Republic, Ecuador, and Peru. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected products if found.
The recalled product
- Product
- Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 15
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)
- Lots 14F18F0336 & 14F18E0121
Distribution
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