Recall Z-2486-2010 ยท HGX Pump, Breast, Powered
Medela Inc
Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; Article #67094S
| Date | Sep 24, 2010 (initiated Aug 6, 2010) |
| Status | Terminated |
| Reason | The product sterility may be compromised due to possible pinholes in the rigid tray of the package. |
| Root cause | Packaging |
| Action | Medela sent Important Device Recall letters dated August 6, 2010 to all direct accounts, identifying the affected product, the labeling issue, and actions to be taken by the customer. The accounts were informed that the sterility of the affected products may be compromised due to holes in the packaging. They were instructed to stop use, sale and distribution of the kits and return their stocks to Stericycle using the enclosed packing slip and prepaid UPS Return Service shipping label. The accounts were requested to complete and return the enclosed postage paid reply card, indicating the amo |
| Quantity | 1,293,304 kits |
| Distribution | Worldwide Distribution: Nationwide throughout USA, including Guam, and to the countries of Barbados, Bermuda, British West Indies, Canada, Panama, Switzerland, Trinidad and Tobago, and Uganda. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K875300 | MEDELA BREAST-PUMP LACTINA Medela, Inc., Apr 6, 1988 |