| Date Initiated by Firm | May 03, 2006 |
|---|
| Date Posted | July 01, 2006 |
|---|
| Recall Status1 |
Terminated 3 on August 09, 2006 |
| Recall Number | Z-1188-06 |
|---|
| Recall Event ID |
35359 |
| 510(K)Number | K033425 |
|---|
| Product Classification |
Intermittent infusion pump - Product Code FRN
|
| Product | ambIT Ambulatory Infusion Therapy Intermittent Pump |
|---|
| Code Information |
Catalog Number: 220245. All serial numbers. |
| FEI Number |
1000117099
|
Recalling Firm/
Manufacturer |
Sorenson Medical, Inc.
1375 W 8040 S
West Jordan
UT
84088-8320
|
| For Additional Information Contact |
801-352-1888 |
|---|
Manufacturer Reason
for Recall | Intermittent Infusion pump may continually dispense medication under certain conditions. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | All direct accounts were contacted by email and phone on 05/03/2006. Distributors were instructed to identify end users for Recalling Firm notification |
|---|
| Quantity in Commerce | 72 pumps |
|---|
| Distribution | Worldwide distribution (including-states of IL, KS, NJ, PA, WA. , countries of Germany, Malaysia, New Zealand, Slovenia. |
|---|
| 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
|
|---|
