ClearanceBrief
Recall Z-0287-2007 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Arrow International Inc

Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-Free A Port. Ref Product No. AP-01510

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.
Quantity204
DistributionNationwide. The firm is NOT recalling from international accounts.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K882230A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED
Therex Corp., Jul 29, 1988
K921475A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM
Therex Corp., Oct 16, 1992