FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1497-04
- 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
- Status
- Terminated
- Initiated
- 2004-08-06
- Posted
- 2004-09-30
- Terminated
- 2004-10-29
- 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.
- Quantity
- not on file
- 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.
- Lot, serial or model codes
- Lot 0404 exp. Oct. 2008; Lot 0417 exp. Jan. 2009; Lot 0419 exp. Jan. 2009.
- 510(k) numbers
- ["K030032"]
- PMA numbers
- not on file
- Product code
- FMF
- Firm FEI
- 3003183625
- Firm city
- Ramat Gan
- Firm state
- not on file
- Firm country
- Israel
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28