Recall Z-1898-2008 ยท FRN Pump, Infusion
Curlin Medical Llc
Model 4000 CMS Ambulatory Infusion Pump, Model Number: 350-1101
| Date | Sep 22, 2008 (initiated May 30, 2008) |
| Status | Terminated |
| Reason | Over-delivery/free-flow involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow. |
| Root cause | Other |
| Action | On May 30, 2008, Curlin Medical began distribution of a "Voluntary Field Correction Advisory Notice" to all customers in the United States via USPS Registered Mail. The Notice informed customers of the problem and gave the customers (1) Guidelines on testing pump volumetric accuracy, (2) Updated user manuals to elevate the "caution" statement related to dropped pumps to a "warning" statement, and (3) A warning label to be located on the pump: "Warning: Impact may cause damage. If dropped, pump must be checked for accuracy prior to use". A toll free number (888-287-5999) was given for customer |
| Quantity | 39,366 units for all affected products/models total |
| Distribution | Worldwide Distribution --- including USA and countries of Australia, Croatia, Germany, Italy, New Zealand, and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981816 | CUE AMBULATORY VOLUMETRIC INFUSION PUMP Becton Dickinson Curlin, LLC, Dec 4, 1998 |