Recalls / —

—#35973

Product

Angiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir.

FDA product code

DQO — Catheter, Intravascular, Diagnostic

Device class

Class 2

Medical specialty

Cardiovascular

510(k) numbers

K884823, K932188, K933700, K942329

Affected lot / code info

List Numbers: 4204201 Lot Numbers: 13193SN; 15171SN; 17151SN

Why it was recalled

Syringes could possibly allow air to enter the patient's vascular system.

Root cause (FDA determination)

Other

Action the firm took

Consignees were notified by letter on 11/10/04 or by telephone on 11/11/04.

Recalling firm

Firm

Hospira Inc.

Address

275 N Field Dr, Lake Forest, Illinois 60045-2579

Distribution

Distribution pattern

Domestic distribution: Nationwide, including 2 military/VA facilities. International distribution: Spain, Belgium, Greece, Japan, and France.

Timeline

Recall initiated

2004-11-02

Posted by FDA

2005-03-15

Terminated

2005-07-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #35973. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.