Date Initiated by Firm |
November 02, 2004 |
Date Posted |
March 15, 2005 |
Recall Status1 |
Terminated 3 on July 25, 2005 |
Recall Number |
Z-0617-05 |
Recall Event ID |
30478 |
510(K)Number |
K942329 K933700 K932188 K884823
|
Product Classification |
Catheter, Intravascular, Diagnostic - Product Code DQO
|
Product |
Angiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir. |
Code Information |
List Numbers: 4204004 Lot Numbers: 15173SN; 19104SN |
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 |
2050 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
|