Vision Hollow Fiber Oxygenator with GBS Coating
FDA device recall Z-0730-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Gish Biomedical Inc
- Reason for recall
- Customers reported leakage.
- Action taken
- Firm issued recall letters to all customers on March 4, 2004 listing lot numbers and quantities shipped to them. Returns were requested.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 950
- Distribution
- NY, PA, AR, IN, IL, NH, SC, NJ, MS, MI, WI, CT, CA
- Date initiated
- 2004-03-04
- Date posted
- 2004-07-20
- Date terminated
- 2005-01-04
- Location
- Rancho Santa Margarita, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATING (K023381) | Gish Biomedical, Inc. | 2003-03-31 |