FDA-Device2012-06-27Class II
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.
Genzyme Corporation
Hazard
Sterility of product may be compromised due to packaging defect
Sold states
Worldwide Distribution - US (nationwide) and the country of S. Korea
Affected count
3880units
Manufactured in
31,45,49,51,55,74,76, & 80 New York Ave., N/A, Framingham, MA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1855-2012Don't want to check this manually?
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