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
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