Recall Z-1224-2011 ยท HGX Pump, Breast, Powered
Medela Inc
Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the affected breast pumps were sold in the following configurations: a) article 57027 - Kit PNSA Shoulder Bag; b) article 57027T - Kit PNSA Shoulder Bag Tagged; c) article 57036T - Kit PNSA
| Date | Feb 11, 2011 (initiated Jan 10, 2011) |
| Status | Terminated |
| Reason | The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected pumps may not turn on, may turn off on its own, may reduce or lose suction during the pumping process, or may make a clicking noise. |
| Root cause | Vendor change control |
| Action | This firm, Medela, sent an "Important Device Recall" letter dated January 11, 2011 to all of direct accounts via UPS or US Mail. The accounts were informed that a component on the control board, after a period of usage, may cause the motor to slow down or stop, resulting one or more of the following symptoms: the pump will not turn on; the pump turns off on its own; the pump reduces or loses suction during the pumping process or the pump is making a clicking noise. If the users have a pump that exhibits any of these symptoms, they were requested to visit Medela's website at www.medelareturns |
| Quantity | 11,154 units |
| Distribution | Nationwide, including Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031614 | MEDELA PUMP IN STYLE ADVANCED BREAST PUMP Medela, Inc., Jun 6, 2003 |