The Recall Desk
ModerateFDA (Devices)·Z-0648-2018·Announced 2018-02-28

Arrow International Recalls Central Venous Catheter Kits with Incorrect Guide

Arrow International is recalling 5,926 central venous catheterization kits distributed nationwide 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, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Arrow International Inc is recalling 5,926 units of Multi Lumen Central Venous Catheterization Kits with Blue FlexTip Catheter and Sharps Safety Features. The affected product code is ASK 15703 NYP, with expiration dates ranging from February 2018 to November 2018. The specific lot number is 13F16M0196.

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

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
Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter and Sharps Safety Features; Product Code: ASK 15703 NYP; 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: 13F16M0196

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 →