Arrow International Recalls Large-Bore CVC Kits Due to Needlestick Risk
Arrow International is recalling specific large-bore central venous catheter kits because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (needlestick injury) where the hazard is a physical injury risk rather than a high-risk pathogen or confirmed severe injury report, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Arrow International Inc. has initiated a recall of the ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit. The recall is driven by reports that the safety cover on the BD Eclipse Needle, which is packaged with certain Arrow products, may disengage. This defect creates a risk of needlestick injury for healthcare professionals using the device.
The affected product is a large-bore multiple-lumen catheter designed to permit venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins. The specific material number for the recalled items is CDA-25123-1A. The firm reports that a total of 43,394 devices were distributed nationwide.
Healthcare facilities and users should stop using the affected kits and contact Arrow International for instructions on how to return or dispose of the products. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- ARROWg+ard Blue Large-Bore Multi-Lumen CVC Kit The large-bore multiple-lumen catheter permits venous access to the central circulation for rapid fluid administration. It may be inserted into the jugular, subclavian, or femoral veins
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 43,394
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)
- Material number CDA-25123-1A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 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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