ClearanceBrief
Recall Z-0620-05 ยท DQO Catheter, Intravascular, Diagnostic

Hospira Inc.

Angiographic Syringe, 12 cc Palm Pad with Rotator Reservoir.

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.
Quantity0 syringes
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

K884823TRANSPAC(R) II, DISPOSABLE TRANSDUCER
Abbott Laboratories, Jul 3, 1990
K932188SAFESET RESERVOIR
Abbott Laboratories, Oct 25, 1993
K933700DYE MANAGEMENT SYSTEM
Abbott Laboratories, Nov 3, 1993
K942329HAND CONTROLLED SYRINGE
Abbott Laboratories, Jun 20, 1994