Deltec CADD-Prizm PCS II Ambulatory Infusion Pump with Revision E Software
FDA Recall Z-0980-03 · Posted 2003-07-03
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Recalling FirmDeltec, Inc
Recall StatusTerminated
Product CodeFRN
Date Initiated2003-06-23
Date Terminated2004-07-02
Product Quantity135 pumps
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.
Firm 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.
Root Cause
Other
Distribution Pattern
The product was distributed only to two hospitals, one in North Carolina and one in Washington State.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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