510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0690-2018Class II

ARROW PICC powered by ARROW VPS Stylet

Arrow International Inc began a recall of ARROW PICC powered by ARROW VPS Stylet on . FDA classified it as Class II and gives the reason as "The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0690-2018
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Arrow International LLC (subsidiary of Teleflex Incorporated)
Product
ARROW PICC powered by ARROW VPS Stylet
Product code
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall
The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter.
FDA root cause
Mixed-up of materials/components
Action
On October 17, 2017 an URGENT Medical Device Recall letter titled "ARROW PICC powered by ARROW VPS Stylet" was mailed to customers instructing them to review inventory and quarantine all affected product which will be returned to the firm. Questions or concerns can be directed to Customer Service at 18662466990.
Quantity in commerce
601 eaches
Distribution
AZ, CA, GA, MA, MO, NY, VA
Product codes and lots
CDC 34041 VPS Lot# 23F17A0037 23F17B0035

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0690-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0690-2018Class IITerminatedVoluntary: Firm initiated