ClearanceBrief
Recall Z-0044-2007 ยท NGT Saline, Vascular Access Flush

Excelsior Medical Corp

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.

DateOct 19, 2006 (initiated Apr 24, 2006)
StatusTerminated
ReasonThe syringe manufacturer mixed a pre-printed heparin labeled flush syringe with the saline syringes.
Root causeOther
ActionExcelsior notified Hospira of the recall on 4/24/2006. Hospira notified Morris Dickson and Cardinal Health on 4/28/2006.
Quantity466,000 units
DistributionWorldwide.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.