Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0044-2007

0.9% Sodium Chloride Flush Syringe, 2.5 mL

Excelsior Medical LLC / initiated 2006-04-24 / Terminated / root cause: labeling and UDI

Excelsior Medical Corp began a recall of 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... on . The reason FDA records is "The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-0044-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Excelsior Medical LLC
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.
Product code
NGT Saline, Vascular Access Flush
Reason for recall
The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.
Root cause tag
labeling and UDI
FDA root cause
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.
Product codes and lots
Product E0100-30, Lot 22-010-9D