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Gyrus Medical, Inc recalls GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF
Recalled August 28, 2013 · FDA recall Z-1983-2013 · Gyrus Medical
Hazard
On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life. · FDA Class II
Units
1140
Sold at
Worldwide Distribution - USA (nationwide) including the states of AL, AZ, CA, FL, GA, IL, IN, KS,KY, MD, MA, MI, MN, MS, MO, NY, NC, OH, PA, SD, TN, TX, VA and WI., and the countries of BRAZIL, CHINA, AUSTRALIA, CHINA, GERMANY and INDIA.
Description
On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.
Product
GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
Manufacturer(s)
Gyrus Medical, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →