Arrow Multi-Lumen CVC Kit Recalled for Labeling Inconsistencies
Arrow International is recalling 3,640 units of the AGB+ Multi-Lumen CVC Kit because some labels incorrectly state the spring-wire guide size as .032 instead of .025.
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 involves minor labeling errors regarding the spring-wire guide size, which fits the rubric for moderate severity.
Plain-English summary
Arrow International Inc is recalling 3,640 units of the Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A. The recall is due to labeling inconsistencies where the lidstock, banner card, or shipper label incorrectly states the Spring Wire Guide (SWG) size as .032 rather than the correct .025. In some lots, the lidstock is correct while the banner card is incorrect.
The affected lots are 13F17E0685, 13F17F0562, 13F17H0141, 13F17K0340, 13F18B0119, and 13R17E0685. These products were distributed nationwide in California, Florida, Idaho, Illinois, Michigan, North Carolina, New Jersey, Pennsylvania, and Wisconsin. The catheter is intended to provide venous access to the central circulation and help protect against catheter-related infections, but it is not intended for long-term use or as a treatment for existing infections.
Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected kits. They should contact Arrow International Inc for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian…
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 3,640
Distribution
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