The Recall Desk
ModerateFDA (Devices)·Z-0652-2018·Announced 2018-02-28

Arrow International Recalls Central Venous Catheter Kits with Incorrect Guide

Arrow International 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. The source text identifies a component defect (incorrect Springwire Guide) but does not report any illnesses, injuries, or deaths, fitting the criteria for a moderate severity recall involving a potential risk of harm without reported adverse events.

Plain-English summary

Arrow International Inc is recalling 5,926 units of the Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features. The recall affects product code ASK-12703-WMC1 with expiration dates ranging from February 2018 to November 2018. The specific lot number is 23F17C0757.

The recall was initiated because these finished good kits may contain the incorrect Springwire Guide (SWG). The products were distributed nationwide in the United States.

Healthcare facilities and consumers should stop using these specific kits and contact Arrow International Inc for further instructions or a replacement.

The recalled product

Product
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; 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: 23F17C0757

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 →