Recall Z-0035-2011 ยท NGT Saline, Vascular Access Flush
Excelsior Medical Corp
Excelsior Disposable Syringe W/Normal Saline (0.9% sodium Chloride) General hospital use
| Date | Oct 20, 2010 (initiated Sep 2, 2010) |
| Status | Terminated |
| Reason | There is the potential for a dimensional issue in 6 ml syringe products, codes E0100-50, 10056-1000, 10056-240, 14056-240, 910056-1000, S5, to cause leakage and.or loss of sterility |
| Root cause | Device Design |
| Action | Excelsior Medical sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 2, 2010, to all customers. The letter described the product, problem and action to be taken by the customers. The customers were instructed to discontinue using syringes from the listed lots and return the attached Customer Reply Form via fax (866) 688-3185 as confirmation that notification had been received and that proper arrangements can be made to have the product returned to the firm. The customers were also instructed to inform their customers, if they have resold products, of the recall and instruct them to |
| Quantity | 13,734,640 |
| Distribution | Worldwide distribution: USA and countries including Canada and Brazil. |
| FDA record | Open on fda.gov |