Devices

Dynarex, Evergreen, Mada and Hospitak.

  • Model / Serial
    Product ID # 5801; Lot numbers 07-39, 07-49; Product ID # 12-8713; lot numbers: 04-08 04-18 04-28 06-11 06-26 07-07 07-12 07-14; Product ID # 732-E; lot numbers: 03-11 03-22 03-25 03-29 03-34 03-42 04-05 04-42 05-12 05-32 05-34 05-42 05-43 06-04 06-19 06-30 07-12 07-20 07-25 07-30 07-35 07-38 07-43 07-47; Product ID # 2206; lot number: 04-05.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam.
  • Product Description
    Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. || Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. || Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
  • Manufacturer
    Unomedical
  • 1 Event

Manufacturer

Unomedical
  • Manufacturer Address
    Unomedical, 5701 S Ware Rd, Mcallen TX 78503-7795
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    USFDA

One device with a similar name

Learn more about the data here

Dynarex, Evergreen, Mada and Hospitak.
  • Model / Serial
    Product ID #: 5804; Lot numbers 07-39, 07-49; Product ID #: 12-8709: Lot numbers: 03-46 03-47 04-42 04-43 06-40 06-43 06-46 06-49; Product ID#: 727-E; lot numbers: 03-17 03-19 03-22 03-25 03-28 03-29 03-33 03-34 03-42 03-45 04-05 04-21 04-31 04-33 04-39 04-40 04-41 04-50 04-51 05-17 05-20 05-32 05-34 05-47 06-04 06-13 06-22 06-25 06-30 06-39 06-40 06-47 06-51 07-07 07-08 07-25 07-29 07-34 07-36 07-42 07-44: Denmark: 04-05; Japan: 06-25 06-30; Mexico: 03-02 03-03 03-40 03-42 03-45 04-05 04-19 04-21 04-37 05-32 05-34 05-42 06-04 07-20 07-29 07-34 07-42 07-44 Peru: 02-36; Product ID # 727MM, Czech Republic lot 07-28; Japan: 07-14    Product ID # 2203; lot numbers: 03-19 03-20 03-31 03-32 03-47 04-13 04-19 04-34 04-45 04-46 05-08 Product ID # 727MM, lot codes: Poland: 05-07; Italy: 06-38 07-11; Denmark: 06-04 07-28 07-36
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam.
  • Product Description
    Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. || Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
  • Manufacturer
    Unomedical