Device product
GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
Z-0100-2015
Product summary
- Event
- Event 69226
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5520 US, 40 OUS
- Official record key
device-enforcement:Z-0100-2015
Official wording
Reason: Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
Code information: All product manufactured before July 28, 2014.
Distribution pattern: Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA.
Derived failure modes
-
Labeling or packaging
packaging process, it is possible that a defective seal could be present that may allow a breach
-
Sterility assurance
breach of the package's sterile barrier