Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2492-2010

Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue Catheter

Arrow International Inc began a recall of Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue Catheter on . The reason FDA records is "Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2492-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arrow International LLC (subsidiary of Teleflex Incorporated)
Product
Two-Lumen Central Venous Catheterization kit with Blue FlexTip Catheter, ARROW g+ard Blue Catheter
Product code
DQY Catheter, Percutaneous
Reason for recall
Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle
FDA root cause
Mixed-up of materials/components
Action
The recalling firm issued an Urgent Medical Device Recall letter dated 7/23/2010 along with a a recall acknowledgement and stock status form.
Quantity in commerce
2
Distribution
The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.
Product codes and lots
Product # CA-22702, Lot # RF0033779