Class 2 Device Recall Angiographic Syringe

• Date Initiated by Firm: November 02, 2004
• Date Posted: March 15, 2005
• Recall Status: Terminated on July 25, 2005
• Recall Number: Z-0620-05
• Recall Event ID: 30478
• 510(K)Number: K884823 K932188 K933700 K942329
• Product Classification: Catheter, Intravascular, Diagnostic - Product Code DQO
• Product: Angiographic Syringe, 12 cc Palm Pad with Rotator Reservoir.
• Code Information: List Numbers: 4204801 Lot Numbers: 14182SN
• Recalling Firm/ Manufacturer: Hospira Inc.; 275 N Field Dr; Lake Forest IL 60045-2579
• For Additional Information Contact: Hospira Customer Care; 877-946-7747
• Manufacturer Reason for Recall: Syringes could possibly allow air to enter the patient's vascular system.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on 11/10/04 or by telephone on 11/11/04.
• Quantity in Commerce: 0 syringes
• Distribution: Domestic distribution: Nationwide, including 2 military/VA facilities. International distribution: Spain, Belgium, Greece, Japan, and France.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQO