ClearanceBrief
Recall Z-0280-2007 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Arrow International Inc

Implantable Vascular Access system -- Infusion Ports with Silicone Rubber Catheter. Latex-Free Low Profile Port. 10 Fr. Introducer Kit Ref Product No. AP-06022

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.
Quantity1924
DistributionNationwide. The firm is NOT recalling from international accounts.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K790882LEAD INTRODUCER SET
Introstat, Jun 11, 1979
K933316THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEM
Therex Corp., Feb 23, 1994