Recall Z-2386-2011 ยท OHH Breast Pump Kit
Medela Inc
AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010. Converting 120 Volt AC power to 9 Volt DC power used for providing power to the Pump In Style Advanced Breast pumps.
| Date | May 27, 2011 (initiated Apr 4, 2011) |
| Status | Terminated |
| Reason | The power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords that may easily become damaged if not properly handled. |
| Root cause | Device Design |
| Action | Medela Inc., sent an " IMPORTANT FIELD ACTION " letter dated April 4, 2011, to all affected customers via The United States Postal Service ( USPS) United Parcel Service ( UPS) and E-mail .The letter identified the product, the problem, and the action to be taken by the customer. It was discovered the power adaptor/transformer used with the Pump in Style Advanced family of breast pumps can develop damage in the form of twists, kinks, bends, bulges or exposed wires in the power cord. Use of the power adaptor with a damaged cord could result in a short in the cord resulting in sparks, smoke, |
| Quantity | 17,681 units alone, 461,142 units with products |
| Distribution | Worldwide Distribution - Nationwide Distribution and Puerto Rico and countries of Canada, Bermuda, Cayman Islands, Hong Kong and Haiti. CHI-DO proposes phone call audit checks of 2 consumers, 2 retailers and 1 hospital account by each district. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950750 | MEDELAS BREAST PUMP Medela, Inc., Oct 16, 1995 |