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U.S. Department of Health and Human Services

Class 2 Device Recall Syrex

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  Class 2 Device Recall Syrex see related information
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/
Excelsior Medical Corp
1923 Heck Ave
Neptune NJ 07753-4428
For Additional Information Contact Himanshu Naik
Manufacturer Reason
for Recall
The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.
FDA Determined
Cause 2
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

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.