Device Recall Pump in Style Advanced Breast Pump

  • Model / Serial
    manufacture dates 02/10/10 through 03/03/10
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including Puerto Rico
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medela Inc, 1101 Corporate Dr, Mchenry IL 60050-7006
  • Manufacturer Parent Company (2017)
  • Source
    USFDA