Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001
FDA device recall Z-0433-05 · posted 2005-01-26 · Terminated
Recall details
- Recalling firm
- Harvard Clinical Technology
- Reason for recall
- Potential pump motor/encoder assembly failure may cause over infusing medication in patients
- Action taken
- Harvard Clinical Technology notified consignees by letter on 11/3/04. Harvard will contact consignees by telephone to schedule a return. The motors inside the recalled products will be replaced at Harvard Clinical. Harvard will provide Loaner pumps upon request during the repair process.
- Root cause
- Other
- Status
- Terminated
- Product code
- MEA
- Quantity affected
- 204 units
- Distribution
- AK, KY, TX, MA, NY, CA, GA, OK, IL, CT, LA, FL, MD,NC, NJ, VA, MI, WI, IA, WV,OH,
- Date initiated
- 2004-11-03
- Date posted
- 2005-01-26
- Date terminated
- 2012-05-07
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HARVARD 1 SYRINGE PUMP/HARVARD 1 WITH PCA SYRINGE PUMP (K033054) | Harvard Clinical Technology | 2003-12-16 |