Device Recall Genzyme

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

Obstetrical and Gynecological Devices

3

No

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

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.

Lot Numbers Affected: RM00654  RM00664  RM00672  RM00687  RM00690  RM00698  RM00700  RM00711  RM00714  RM00727  RM00732  RM00741  RM00748  RM00757  RM00773  RM00781  RM00791  RM00802 RM00820 RM00835

General and Plastic Surgery Devices

2

No

Nationwide

Genzyme Biosurgery Essentials Kit, Item Number 82004

Lot 37772  Exp. Date: May 2011

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide distribution: USA including states of: KY, PA, NV, and WA and country of Canada.

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.