Medela Inc

manufacture dates 02/10/10 through 03/03/10

Obstetrical and Gynecological Devices

2

No

Nationwide, including Puerto Rico

Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the affected breast pumps were sold in the following configurations: || a) article 57027 - Kit PNSA Shoulder Bag; || b) article 57027T - Kit PNSA Shoulder Bag Tagged; || c) article 57036T - Kit PNSA The Metro Bag Tagged; || d) article 57043 - PNSA without kit; || e) article 57062 - Kit PNSA Backpack; || f) article 57062-03 - Kit PNSA Backpack CA/3; || g) article 57062T - Kit PNSA Backpack Tagged; || h) 57102 - Motor Replacement PNSA Backpack 57062; || i) 57103 - Motor Replacement PNSA Shoulder Bag 57027 || Intended use: A powered breast pump for the removal, collection and storage of mother's breast milk.

item #1908095, revision B 0909, contained in kits shipped between 10/23/09 and 02/02/2010

Obstetrical and Gynecological Devices

2

No

Nationwide distribution

Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user accessory kits for use with Symphony breast pumps: || a) Model 67023, Harmony to Symphony Conversion Kit; || b) Model 67091, Lactina to Symphony Conversion Retail Kit; || c) Model 67099, Symphony Retail Kit; || d) Model 67099-06, Symphony Retail Kit - case of 6 kits; || e) Model 67099NA, Symphony Retail Kit - case of 6 kits for national accounts;

product code 0877061, lot 370118, some of which were mislabeled as product 0877067, lot 370118

General and Plastic Surgery Devices

2

No

Nationwide Distribution including the states of California, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Mississippi, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee and Texas.

Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. || Medela Healthcare, || McHenry, IL 60051; || A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case; || Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit, 15 Fr Round Channel Drain, product 0877067, lot 370118

article number 67203S, lot numbers 358789, 359716, 360440, 360632, 364515, 366388, 366492, 366570, 366682, 366702, 366705, and 366806.

General Hospital and Personal Use Devices

1

No

Nationwide distribution: USA including states of: AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, MA, MD, ME,MI, MN, MS, MT, NC, ND, NH, NJ, NY, OH, OK, PA, SC, TX, UT, VA, VT, WA, WI, and WV.

Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care only; Manufactured for Medela, Inc., P.O. Box 660, McHenry, IL 60051-0660, Made in Switzerland; article #67203S || Individually wrapped for immediate use. For latch-on difficulties. Made of silicone. For use under professional care only while breastfeeding the baby.

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

Obstetrical and Gynecological Devices

2

No

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.

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.