Z-1497-04

Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single...

Name: Z-1497-04 Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single...
Creator: Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst.
Published: 2004-08-06
License: https://open.fda.gov/license/

Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst. / initiated 2004-08-06 / Terminated

FDA source

Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst. began a recall of Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by... on 2004-08-06. The reason FDA records is "5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1497-04
Status: Terminated
Initiated: 2004-08-06
Posted: 2004-09-30
Terminated: 2004-10-29
Recalling firm: Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst.
Product: 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
Product code: FMF Syringe, Piston
Reason for recall: 5 mL Crosseal fibrin sealant (human) is difficult to expel from the device resulting in product leakage from the vial insertion port .
FDA 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.
Product codes and lots: Lot 0404 exp. Oct. 2008; Lot 0417 exp. Jan. 2009; Lot 0419 exp. Jan. 2009.

Product code FMF

K030032Class IICrosseal Application DeviceOmrix Biopharmaceuticals, Inc. / cleared 2003-03-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)