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Recall Observatory FDA recall evidence

Device product

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.

Z-1855-2012

June 13, 2012

Class II

Product summary

Firm
Genzyme Corporation
Event
Event 62127
Status
Terminated
Classification
Class II
Quantity
3880units
Official record key
device-enforcement:Z-1855-2012

Official wording

Reason: Sterility of product may be compromised due to packaging defect

Code information: Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11

Distribution pattern: Worldwide Distribution - US (nationwide) and the country of S. Korea

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    packaging defect
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Sterility of product may be compromised due to packaging defect