Recall Z-1442-2010
Medela Inc · initiated March 15, 2010
Product
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; d) Model 67099-06, Symphony Retail Kit - case of 6 kits; e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts;
Codes / lots: item #1908095, revision B 0909, contained in kits shipped between 10/23/09 and 02/02/2010
Reason for recall
The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do not require cleaning before first use.
FDA-determined cause: Labeling Change Control
Action taken
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 clarification on the recall.
Details
- Recall number
- Z-1442-2010
- Initiated
- March 15, 2010
- Posted by FDA
- April 27, 2010
- Terminated
- December 10, 2010
- Product code
- HGX – Pump, Breast, Powered
- Quantity
- 13,834 kits
- Distribution
- Nationwide distribution
- Recalling firm
- Medela Inc, Mchenry, IL