Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
FDA device recall Z-0980-03 · posted 2003-07-03 · Terminated
Recall details
- Recalling firm
- Deltec, Inc
- Reason for recall
- Pump keyboard entries by the patient could have resulted in the patient having unintended access to programming screens and led to in improper drug dosage.
- Action taken
- A recall letter, sent to the consignees on June 23, stated that the firm would telephone the consignees to arrange the correction of their affected pumps by reprogramming with the new software.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 135 pumps
- Distribution
- The product was distributed only to two hospitals, one in North Carolina and one in Washington State.
- Date initiated
- 2003-06-23
- Date posted
- 2003-07-03
- Date terminated
- 2004-07-02
- Location
- St 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 |