ClearanceBrief
Recall Z-0285-2007 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Arrow International Inc

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. 6 Fr. Introducer Kit. Ref Product No. AP-06014

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.
Quantity94
DistributionNationwide. The firm is NOT recalling from international accounts.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K921379A-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