The Recall Desk
ModerateFDA (Devices)·Z-0647-2018·Announced 2018-02-28

Arrow International Recalls Central Venous Catheterization Kits Due to Incorrect Guide

Arrow International Inc is recalling 5,926 Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen 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 or injuries, fitting the criteria for a moderate severity recall involving a potential defect without confirmed harm.

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 (Product Code: ASK 42703 PUHC). The affected products have expiration dates ranging from February 2018 to November 2018 and are identified by Lot number 23F16M0054. These kits were distributed nationwide in the United States.

The recall was initiated because the finished good kits may contain the incorrect Springwire Guide (SWG). The source text does not report any illnesses, injuries, or deaths associated with this defect.

Healthcare facilities and consumers should stop using the affected kits and contact Arrow International Inc for further instructions or a return.

The recalled product

Product
Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous Catheterization Kit; Product Code: ASK 42703 PUHC; 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: 23F16M0054

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 →