ClearanceBrief
Recall Z-0282-2007 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Arrow International Inc

Implantable Vascular Access system --Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 9 Fr. Introducer Kit. Ref. Product No. AP-06018.

DateDec 19, 2006 (initiated Sep 29, 2006)
StatusTerminated
ReasonCatheter has separated from the infusion port body.
Root causeOther
ActionThe recall notification was sent out to their US customers on 9/29/2006.
Quantity452
DistributionNationwide. The firm is NOT recalling from international accounts.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K922434A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM LINE EXT
Therex Corp., Nov 6, 1992
K926011A-PORT IMPLANT VASCU ACCESS SYST PROD LIN EXT-MODI
Therex Corp., Mar 19, 1993