Medical Device
Manufacturing
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Z-2496-2010

Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter

Arrow International Inc began a recall of Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+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-2496-2010
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arrow International LLC (subsidiary of Teleflex Incorporated)
Product
Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter
Product code
FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
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
5
Distribution
The product was shipped to medical centers and hospitals nationwide and to Australia, New Zealand, and Europe.
Product codes and lots
Product # NR-22802-B, Lot # RF0033406