| | Class 2 Device Recall |  |
| Date Initiated by Firm | November 03, 2004 |
|---|
| Date Posted | January 26, 2005 |
|---|
| Recall Status1 |
Terminated 3 on May 07, 2012 |
| Recall Number | Z-0431-05 |
|---|
| Recall Event ID |
30301 |
| 510(K)Number | K952794 |
|---|
| Product Classification |
Pump, Infusion - Product Code FRN
|
| Product | Harvard 2 Dual Channel Syringe Infusion Pump
P/N 2001-001 |
|---|
| Code Information |
Serial number range: 208002251 - 408203175 |
| FEI Number |
1218257
|
Recalling Firm/
Manufacturer |
Harvard Clinical Technology
22 Pleasant Street
Natick MA 01760
|
| For Additional Information Contact | Daniel B. Laferriere
781-596-7750 |
|---|
Manufacturer Reason
for Recall | Potential pump motor/encoder assembly failure may cause over infusing medication in patients |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | 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. |
|---|
| Quantity in Commerce | 975 units |
|---|
| Distribution | AK, KY, TX, MA, NY, CA, GA, OK, IL, CT, LA, FL, MD,NC, NJ, VA, MI, WI, IA, WV,OH, |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = FRN
|
|---|
|
|
|
