Arrow International Recalls Central Venous Access Kits Due to Packaging Seal Issues
Arrow International is recalling specific central venous access kits because packaging may not be completely sealed, potentially compromising sterility.
What this means for you
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 the hazard involves a potential sterility compromise due to packaging issues. This aligns with the rubric for moderate severity, as it represents a risk of harm without reported injuries or fatalities.
Plain-English summary
Arrow International is recalling certain ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kits and ARROWg+ard Blue PSI Kits. The recall is being conducted because the packaging for these devices may not be completely sealed, which could compromise the sterility of the product.
The affected products are central venous access devices used to permit venous access and catheter introduction to the central circulation, typically inserted into the jugular, subclavian, or femoral veins. The recall covers 27,485 units distributed in the U.S. and 4,371 units distributed internationally, with distribution patterns including nationwide U.S. and Canada.
Healthcare providers and consumers should check their inventory for the specific material numbers listed in the recall notice: CDA-21242-1A, CDA-29803-1A, CDC-21242-1A, CDC-29803-1A, and CDC-29903-1A. If the packaging is found to be unsealed or compromised, the devices should not be used.
The recalled product
- Product
- 1) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 2) ARROWg+ard Blue PSI Kit 3) ARROWg+ard Blue MAC Two-Lumen Central Venous Access Kit 4) ARROWg+ard Blue PSI Kit The MACTM two-Lumen Central Venous Access Device with ARROWg+ard Blue permits venous access and catheter
- Manufacturer
- Arrow International Inc
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 (5)
- Material number: CDA-21242-1A
- CDA-29803-1A
- CDC-21242-1A
- CDC-29803-1A
- CDC-29903-1A Device Listing D025768
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 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.
See all 12 products in this recall →Related recalls
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