Recall Z-0980-03 ยท FRN Pump, Infusion
Deltec, Inc
Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
| Date | Jul 3, 2003 (initiated Jun 23, 2003) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 135 pumps |
| Distribution | The product was distributed only to two hospitals, one in North Carolina and one in Washington State. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000842 | CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM Sims Deltec, Inc., Jun 8, 2000 |