Arrow International Recalls PICC Catheters Due to Labeling Inaccuracy
Arrow International Inc is recalling 4FR Single Lumen Pressure Injectable PICC catheters because the instructions state they withstand 10 pressure injections, but they are only tested for 5.
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 explicitly states the issue is a labeling inaccuracy regarding pressure injection limits without reporting any illnesses or injuries. This aligns with the rubric for minor labeling errors or low-risk contamination where no harm has been reported.
Plain-English summary
Arrow International Inc is recalling 31,590 units of 4FR Single Lumen Pressure Injectable PICC catheters. These intravascular therapeutic catheters are intended for long-term use greater than 30 days. The recall covers specific material numbers and batch numbers distributed worldwide, including the United States, Australia, Canada, and New Zealand.
The recall is due to a labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The provided documentation states that the PICC can withstand up to ten (10) pressure injections. However, the product has only been tested to withstand five (5) pressure injections. This discrepancy could lead to the catheter being used beyond its tested limits.
Healthcare providers and patients who have these specific PICC catheters implanted should contact their healthcare provider or Arrow International Inc for further instructions. The source text does not report any illnesses or injuries associated with this labeling error.
The recalled product
- Product
- 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 31,590
Distribution
Distributed nationwide across the United States.
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