Date Initiated by Firm |
April 24, 2006 |
Date Posted |
October 19, 2006 |
Recall Status1 |
Terminated 3 on October 26, 2006 |
Recall Number |
Z-0044-2007 |
Recall Event ID |
35960 |
Product Classification |
syringe - Product Code NGT
|
Product |
0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100-30. Manufactured by Excelsior Medical and distributed by Hospira, Lake Forest, IL under Hospira''s label, Syrex. |
Code Information |
Product E0100-30, Lot 22-010-9D |
Recalling Firm/ Manufacturer |
Excelsior Medical Corp 1923 Heck Ave Neptune NJ 07753-4428
|
For Additional Information Contact |
Himanshu Naik 732-643-6080
|
Manufacturer Reason for Recall |
The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.
|
FDA Determined Cause 2 |
Other |
Action |
Excelsior notified Hospira of the recall on 4/24/2006. Hospira notified Morris Dickson and Cardinal Health on 4/28/2006. |
Quantity in Commerce |
466,000 units |
Distribution |
Worldwide. |
Total Product Life Cycle |
TPLC Device Report
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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.
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