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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Event Detail

Event ID 62127
Product Type Devices
Status Ongoing
Recalling Firm Genzyme Corporation
City Framingham
State MA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-13
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution - US (nationwide) and the country of S. Korea

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
seprafilmĀ® 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. Lot number: 11NP685 . Exp 2014- 11 Class II Sterility of product may be compromised due to packaging defect 1285 units Z-1856-2012
seprafilmĀ® 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. Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11 Class II Sterility of product may be compromised due to packaging defect 3880units Z-1855-2012
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