ClearanceBrief
Recall Z-0630-05 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Becton Dickinson Infusion Therapy

Careflow 7Fr x 20cm 3-lumen Central Venous Catheter Tray

DateMar 18, 2005 (initiated Jan 10, 2005)
StatusTerminated
ReasonVarious procedure trays and kits may have an insufficient seal, thus compromising sterility.
Root causeOther
ActionCustomers were contacted by telephone and by letters dated 01/10/05.
Quantity5 units
DistributionDomestic distribution: WI. International distribution: Puerto Rico, Virgin Islands. There were no military or VA facilities.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K033500BD CAREFLOW CENTRAL VENOUS CATHETER
Becton, Dickinson & CO, Jan 29, 2004