Medical Device Recall: Z-0044-2007

FDA Recalls dataset · Firm: Excelsior Medical Corp · Status: Terminated

Recall Action Class: N/A Date Initiated: 2006-04-24 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0044-2007.

Recall Res Number
Z-0044-2007
Recalling Firm / Manufacturer
Excelsior Medical Corp
FEI Number
1000122362
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2006-04-24
Date Posted
2006-10-19
Date Terminated
2006-10-26
Product Code
NGT
Event Number
35960
Product Quantity
466,000 units
Product Description 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.
Reason for Recall The syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.
Action Details Excelsior notified Hospira of the recall on 4/24/2006. Hospira notified Morris Dickson and Cardinal Health on 4/28/2006.
Distribution Pattern Worldwide.
Code Information / Serial Numbers Product E0100-30, Lot 22-010-9D

Related Establishments / Registrations

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