Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0832-03

BD First PICC 3F 65 cm Single Lumen Procedure Kit

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2003-04-04 / Terminated / root cause: labeling and UDI

Becton Dickinson Infusion Therapy began a recall of BD First PICC 3F 65 cm Single Lumen Procedure Kit on . The reason FDA records is "A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0832-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Becton Dickinson Infusion Therapy Systems Inc.
Product
BD First PICC 3F 65 cm Single Lumen Procedure Kit.
Product code
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall
A 4 Fr catheter was packaged in PICC convenience kits labeled as 3 Fr.
Root cause tag
labeling and UDI
FDA root cause
Other
Action
All distributors and known hospitals were notified on 04/04/2003 by telephone, followed by a fax notification.
Quantity in commerce
840 kits
Distribution
Nationwide
Product codes and lots
Reference No. 384134, Lot No. 2326770.