Cruciform Slit Valve
FDA device recall Z-0585-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Phoenix Biomedical
- Reason for recall
- mislabeled - product actually Single Valve
- Action taken
- The recalling firm faxed copies of recall letters to the hospitals informing them of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- JXG
- Quantity affected
- 5 units
- Distribution
- The product was shipped to two hospitals - one in CA and one in AZ.
- Date initiated
- 2004-01-06
- Date posted
- 2004-07-20
- Date terminated
- 2004-03-03
- Location
- Norristown, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| H-H CRUCIFORM-SLIT VALVE (K853363) | Holter-Hausner Intl. | 1985-09-03 |
| VALVE, H-H CRUCIFORM SLIT (K790126) | Holter-Hausner Intl. | 1979-01-26 |