ClearanceBrief
Recall Z-0621-05 ยท DQO Catheter, Intravascular, Diagnostic

Hospira Inc.

Catheterization Kits containing Angiographic Syringes with rotator connector.

DateMar 15, 2005 (initiated Nov 2, 2004)
StatusTerminated
ReasonSyringes could possibly allow air to enter the patient's vascular system.
Root causeOther
ActionConsignees were notified by letter on 11/10/04 or by telephone on 11/11/04.
Quantity62080 kits
DistributionDomestic distribution: Nationwide, including 2 military/VA facilities. International distribution: Spain, Belgium, Greece, Japan, and France.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K932141CARDIAC CATHETERIZATION KIT
Abbott Laboratories, Sep 22, 1994