Recall Z-1497-04 ยท FMF Syringe, Piston
Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst.
Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington, DC 20006, Manufactured by: Medimop Medical Projects Ltd, for OMRIX biopharmaceuticals, Utd, MDA blood bank, Sheba Hospital, Romat-Gan, PO8 888, Kiryat Ono 55000 Israel
| Date | Sep 30, 2004 (initiated Aug 6, 2004) |
| Status | Terminated |
| Reason | 5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port . |
| Root cause | Other |
| Action | American Red Cross was notified of the recall on July 25, 2004. Recall letter to the ARC direct accounts was sent out on 8/9/2004. |
| Distribution | The product was shipped from Israel to the American Red Cross distribution center in Louisville, KY. From there, the ARC would ship the product to other distributors and/or directly to 46 hospitals nationwide. There are no govt accounts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030032 | CROSSEAL APPLICATION DEVICE Omrix Biopharmaceuticals, Inc., Mar 21, 2003 |