Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For U
FDA device recall Z-1497-04 · posted 2004-09-30 · Terminated
Recall details
- Recalling firm
- Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst.
- 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 .
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FMF
- 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 na
- Date initiated
- 2004-08-06
- Date posted
- 2004-09-30
- Date terminated
- 2004-10-29
- Location
- Ramat Gan, Israel
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CROSSEAL APPLICATION DEVICE (K030032) | Omrix Biopharmaceuticals, Inc. | 2003-03-21 |