Devices

Device Recall Genzyme

  • Model / Serial
    Lot number: 11NP685 . Exp 2014- 11
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and the country of S. Korea
  • Product Description
    seprafilm¿ Single Site ADHESION BARRIER || Re-order Number: 6641-01 || Product Usage: || Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
  • Manufacturer
    Genzyme Corporation
  • 1 Event

Manufacturer

Genzyme Corporation
  • Manufacturer Address
    Genzyme Corporation, 31,45,49,51,55,74,76, & 80 New York Ave., Framingham MA 01702-5733
  • Manufacturer Parent Company (2017)
    Sanofi
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

Device Recall Genzyme
  • Model / Serial
    Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11
  • Product Classification
    Obstetrical and Gynecological Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and the country of S. Korea
  • Product Description
    seprafilm¿ Procedure Pack ADHESION BARRIER || Re-order Number: 5086-02 || Product Usage: || Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
  • Manufacturer
    Genzyme Corporation
Device Recall Genzyme Biosurgery Essentials Kit, Item Number 82004
  • Model / Serial
    Lot Numbers Affected: RM00654  RM00664  RM00672  RM00687  RM00690  RM00698  RM00700  RM00711  RM00714  RM00727  RM00732  RM00741  RM00748  RM00757  RM00773  RM00781  RM00791  RM00802 RM00820 RM00835
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Genzyme Biosurgery Essentials Kit, Item Number 82004
  • Manufacturer
    Genzyme Corporation
Device Recall Genzyme Diagnostics Total Serum Cholesterol Kit,
  • Model / Serial
    Lot 37772  Exp. Date: May 2011
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada.
  • Product Description
    Genzyme Diagnostics Total Serum Cholesterol Kit, IVD || Catalog Number: 225-26 || Intended use: For the IN VITRO quantitative measurement of total serum cholesterol in serum.
  • Manufacturer
    Diagnostic Chemicals, Ltd.