FDAClass IIJune 21, 2017

Multi-Lumen Central Venous Catheterization Kit with recall: Sterility Concern

Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen…

Why was Multi-Lumen Central Venous Catheterization Kit with recalled?

Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Material number: ASK-45703-AH, CDC-42703-1A, CDC-42703-1A, CDC-42854-1A, CDC-45703-1A, CDC-45703-A1A, CDC-45703-B1A, CDC-45854-1A, CDC-47702-1A Device Listing D213817

Product
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen…
Recalling firm
Arrow International Inc
Quantity
27,485 units distributed in U.S., 4,371 units distributed internationally
Distribution
Worldwide Distribution - US (nationwide) and Canada
Recall date
June 21, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls