Device recall
Z-1497-04: Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial…
FDA device recall · Class III · Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst.
Key facts
| Recall number (Z-number) | Z-1497-04 |
|---|---|
| Recall event | 29728 |
| 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… |
| Product code | FMF |
| Recalling firm | Omrix Biopharmaceuticals, Ltd. - Plasma Fract. Inst. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 29, 2004 |
| 510(k) numbers | K030032 |
| FEI number | 3003183625 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database