The Recall Desk
ModerateFDA (Devices)·Z-0653-2018·Announced 2018-02-28

Arrow International Recalls Central Venous Catheterization Kits Due to Incorrect Guide

Arrow International Inc is recalling 5,926 central venous catheterization kits because they may contain the incorrect Springwire Guide.

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 source text does not report any illnesses, injuries, or hospitalizations. The defect involves an incorrect component (Springwire Guide) without explicit evidence of high-risk pathogens or immediate severe harm, fitting the criteria for a moderate severity voluntary or precautionary recall.

Plain-English summary

Arrow International Inc is recalling 5,926 units of the Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit. The recall involves product code ASK-45703-PHF2 with expiration dates ranging from February 2018 to November 2018. The specific lot number affected is 23F17D0182.

The recall was initiated because the finished good kits may contain the incorrect Springwire Guide (SWG). The agency has classified this as a Class II recall. The products were distributed nationwide in the United States.

Healthcare facilities and consumers should stop using the affected kits and contact the manufacturer for instructions on return or replacement. No specific instructions for end-users are provided in the source text beyond the identification of the defect.

The recalled product

Product
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018
Affected units
5,926

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)

  • Lot number: 23F17D0182

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 →