Recall Z-1442-2010 ยท HGX Pump, Breast, Powered
Medela Inc
Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user accessory kits for use with Symphony breast pumps: a) Model 67023, Harmony to Symphony Conversion Kit; b) Model 67091, Lactina to Symphony Conversion Retail Kit; c) Model 67099, Symphony Retail Kit
| Date | Apr 27, 2010 (initiated Mar 15, 2010) |
| Status | Terminated |
| Reason | The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use. |
| Root cause | Labeling Change Control |
| Action | An "IMPORTANT:DEVICE RECALL" letter dated March 12, 2010 to the the customers on March 15, 2010, via certified mail, return receipt requested. The letters were tailored to each customer listing the affected shipments sent to them, and informing them of the labeling insert problem. The customers were requested to cease distribution of the affected kits and return them to the firm (Medela) for replacement, and if applicable, to notify their retail customers. The customers were instructed to call Medela Customer Service at 877-320-2301 for assistance in processing returns or for further clarif |
| Quantity | 13,834 kits |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020518 | MEDELA SYMPHONY BREAST PUMP, MODEL 024 Medela, Inc., Mar 7, 2002 |