Deltec branded CADD-Prizm PCS II ambulatory infusion pump and the CADD-Prizm VIP system ambulatory infusion pumps; (Both
FDA device recall Z-0718-2007 · posted 2007-04-05 · Terminated
Recall details
- Recalling firm
- Smiths Medical MD, Inc.
- Reason for recall
- The year of manufacture had been incorrectly entered as 1980 into the pumps software during the manufacture process. As a result the pump may go into an immediate 'Clock battery is Low/Service Immediately' or 'Clock Battery needs service soon' alarm message indicating that the pump requires servicing.
- Action taken
- All consignees who have received the affected CADD-Prizm PCS II ambulatory infusion pumps and the CADD-Prizm VIP System ambulatory infusion pumps were contacted via telephone by February 1, 2007. The problem will be explained to the consignee and they will be asked to return the pumps to Smiths Medical MD in order for the problem to be corrected.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 27
- Distribution
- Nationwide.
- Date initiated
- 2007-01-19
- Date posted
- 2007-04-05
- Date terminated
- 2007-05-25
- Location
- Saint Paul, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM (K000842) | Sims Deltec, Inc. | 2000-06-08 |
| CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM (K973917) | Sims Deltec, Inc. | 1998-01-09 |
| CADD-PRIZM MODEL 6100 PUMP (K960826) | Sims Deltec, Inc. | 1996-08-23 |