Arrow International Recalls Central Venous Catheter Kits Due to Packaging Seal Issues
Arrow International is recalling multi-lumen central venous catheterization 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 compromise of sterility due to packaging issues. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Arrow International is recalling the Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter, and Sharps Safety Features. The recall is being conducted because the packaging may not be completely sealed, which may compromise the sterility of the device.
The affected products are intended to permit venous access to the central circulation via the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is designed to help provide protection against catheter-related infections but is not intended for long-term use or as a treatment for existing infections.
A total of 27,485 units were distributed in the U.S. and 4,371 units were distributed internationally. The distribution pattern includes nationwide distribution in the U.S. and Canada. The affected material numbers include ASK-45703-AH, CDC-42703-1A, CDC-42854-1A, CDC-45703-1A, CDC-45703-A1A, CDC-45703-B1A, CDC-45854-1A, and CDC-47702-1A. The Device Listing number is D213817.
The recalled product
- Product
- Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheters
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 (8)
- Material number: ASK-45703-AH
- CDC-42703-1A
- CDC-42854-1A
- CDC-45703-1A
- CDC-45703-A1A
- CDC-45703-B1A
- CDC-45854-1A
- CDC-47702-1A Device Listing D213817
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.
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