ClearanceBrief
Recall Z-0284-2007 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Arrow International Inc

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 10 Fr. Introducer Kit. Ref. Product No. AP-06015

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.
Quantity890
DistributionNationwide. The firm is NOT recalling from international accounts.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K875214A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
Therex Corp., Feb 19, 1988
K921475A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM
Therex Corp., Oct 16, 1992