The Recall Desk
HighFDA (Devices)·Z-0655-2018·Announced 2018-02-28

Arrow International Recalls Multi Lumen Central Venous Catheterization Kits

Arrow International Inc is recalling specific lots of AGB+ Multi Lumen Central Venous Catheterization Kits because they may contain the incorrect Springwire Guide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the rubric criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Arrow International Inc is recalling 5,926 units of AGB+ Multi Lumen Central Venous Catheterization Kits. The affected product codes are CDC-42703-XP1A and CDC-47702-XP1A, with expiration dates ranging from February 2018 to November 2018. The specific lot numbers involved are 23F16M0507 for code CDC-42703-XP1A and 23F17A0533 for code CDC-47702-XP1A.

The recall was initiated because these 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 check their inventory for these specific product codes, lot numbers, and expiration dates. If the affected products are found, they should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.

The recalled product

Product
AGB+ Multi Lumen Central Venous Catheterization Kit; Product Codes: CDC-42703-XP1A and CDC-47702-XP1A; Exp. Dates Feb 2018 - Nov 2018
Affected units
5,926

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 →