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U.S. Department of Health and Human Services

Class 2 Device Recall AC Adaptor Article 9207010

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  Class 2 Device Recall AC Adaptor Article 9207010 see related information
Date Initiated by Firm April 04, 2011
Date Posted May 27, 2011
Recall Status1 Terminated 3 on October 16, 2012
Recall Number Z-2386-2011
Recall Event ID 58431
510(K)Number K950750  
Product Classification Breast pump kit - Product Code OHH
Product 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.
Code Information Article #9207010 Transformer (The transformer can be found as an individual item shipped with the products listed below) a) 57018W Kit PNSA W/O Bat PK WIC b) 57027 Kit PNSA Shoulder Bag c) 57027-03 Kit PNSA Shoulder Bag CS/3 d) 57027POP Display PNSA e) 57027T Kit PNSA w/Battery Pack f) 57036 Kit PNSA Metro g) 57036-03 Kit PNSA Black Metro h) 57036T 57036-03 Metro Tagged i) 57038 Pump ADV POP Medical Ast. j) 57043 57043 PNSA Without Kit k) 57045W Kit PNSA W/BAT PK WIC l) 57045WT KIT PNSA WIC W/BAT PK m) 57046 PNSA Tote without Kit n) 57062 Kit PNSA Backpack o) 57062-03 Kit PNSA Backpack CAl3 p) 57062T Kit PNSA Tagged Backpack q) 57063 PNSA Tote r) 57063-03 PNSA Tote 3-Pack s) 57063T PNSA Tote Tagged t) 6007113 Kit Motor Replacement Metro 2008
Recalling Firm/
Manufacturer		 Medela Inc
1101 Corporate Dr
Mchenry IL 60050-7006
For Additional Information Contact Mr. Donald J. Alexander
815-578-2406
Manufacturer 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.
FDA Determined
Cause 2		 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, 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.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OHH and Original Applicant = MEDELA, INC.
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