Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051
FDA device recall Z-1442-2010 · posted 2010-04-27 · Terminated
Recall details
- Recalling firm
- Medela Inc
- 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.
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- HGX
- Quantity affected
- 13,834 kits
- Distribution
- Nationwide distribution
- Date initiated
- 2010-03-15
- Date posted
- 2010-04-27
- Date terminated
- 2010-12-10
- Location
- Mchenry, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDELA SYMPHONY BREAST PUMP, MODEL 024 (K020518) | Medela, Inc. | 2002-03-07 |