Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2332-2017·Announced 2017-06-21

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.

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 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
Hazard: sterility-compromise
packaging-defect

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.

See all 12 products in this recall →

Same manufacturer · Arrow International Inc

See all →

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Same hazard · sterility compromise