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U.S. Department of Health and Human Services

Class 2 Device Recall Angiographic Syringe

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  Class 2 Device Recall Angiographic Syringe see related information
Date Initiated by Firm November 02, 2004
Date Posted March 15, 2005
Recall Status1 Terminated 3 on July 25, 2005
Recall Number Z-0618-05
Recall Event ID 30478
510(K)Number K942329  K933700  K932188  K884823  
Product Classification Catheter, Intravascular, Diagnostic - Product Code DQO
Product Angiographic Syringe, 12 cc Thumb Ring with Rotator Reservoir.
Code Information List Numbers: 4204201 Lot Numbers: 13193SN; 15171SN; 17151SN 
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 2		 Other
Action Consignees were notified by letter on 11/10/04 or by telephone on 11/11/04.
Quantity in Commerce 8175 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 and Original Applicant = ABBOTT LABORATORIES
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