Medrad Avanta Multi-patient Disposable Sets. Catalog number AVA 500 MPAT
FDA device recall Z-0083-06 · posted 2005-10-21 · Terminated
Recall details
- Recalling firm
- Medrad Inc
- Reason for recall
- stress crack on the stopcock
- Action taken
- The recalling firm issued letters dated 9/20/05 to the hospitals and sales representative informing them of the problem and the need to return the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- LHI
- Quantity affected
- 850 units
- Distribution
- The products were shipped to medical facilities in CA, CO, DE, FL, IL, MA, NC, OH, PA, and VA. The products were also shipped to sales representatives in CA, CO, FL, MA, MN, MO, OK, PA, SC, and WI. Th
- Date initiated
- 2005-09-20
- Date posted
- 2005-10-21
- Date terminated
- 2006-01-20
- Location
- Indianola, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM (K050456) | Medrad, Inc. | 2005-06-17 |