Exacta-Mix Valve Set, Primary Valve Assembly
FDA device recall Z-0982-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Baxa Corporation
- Reason for recall
- A potential leak situation in the port valve assembly could result in inaccurate ingredient delivery.
- Action taken
- Consignees were notified by phone, fax and letter beginning 4/30/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- LHI
- Quantity affected
- 400 cases (10 per case)
- Distribution
- Nationwide, including 6 military hospitals and two VA facilities. Foreign distribution to Argentina, Brazil, Canada, Columbia, Hong Kong, Korea, Malaysia, Mexico, Panama, Singapore, Taiwan, UK, and Ve
- Date initiated
- 2004-04-30
- Date posted
- 2004-07-20
- Date terminated
- 2004-08-12
- Location
- Englewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP (K900585) | Baxa Corp., Sub. of Cook Group, Inc. | 1990-04-18 |