AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Me
FDA device recall Z-2386-2011 · posted 2011-05-27 · Terminated
Recall details
- Recalling firm
- Medela Inc
- Reason for recall
- 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.
- Action taken
- 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, burning and melting of the transformers. If the users have a damaged power adaptor or power adaptor cord, they were requested to discontinue use of the adaptor and visit Medela's website at www.poweradaptorhelp.com to request a replacement adaptor. Questions about the recall process were directed to Medela Customer Service at 1-855-367-0104 or e-mail at poweradaptor@medela.com. Distributor/retailers were requested to post the recall notice within their establishment visible to their customer base, and to notify their customers of the recall. Information on the recall was posted on Medela's website www.medelapoweradaptorhelp.com on April 4, 2011.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OHH
- Quantity affected
- 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 retail
- Date initiated
- 2011-04-04
- Date posted
- 2011-05-27
- Date terminated
- 2012-10-16
- 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 |
|---|---|---|
| MEDELAS BREAST PUMP (K950750) | Medela, Inc. | 1995-10-16 |