BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0100-2015 · Initiated August 27, 2014

    Recall

    Recall Number
    Z-0100-2015
    Event Number
    69226
    Firm
    Gyrus Medical, Inc
    FEI Number
    3011050570
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 27, 2014
    Posted
    October 21, 2014
    Terminated
    September 15, 2015
    Address
    6655 Wedgwood Rd N, Ste 160, Osseo, MN, 55311-3613

    Description

    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.

    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.

    Action

    Olympus sent a Medical Device Recall letter dated August 26, 2014, via FEDEX to all affected consignees. The letter described the issue and the product involved in the recall. It also described the action that the consignee needs to take. Consignees were instructed to cease further use of the device, quarantine it and return it to the manufacturer.Consigness were instructed to complete and return by fax (484-896-7128) the questionnaire enclosed. If the product was further distributed consignees should notify their customers of the product recall. For additional information they can call 484-896-5688. For questions regarding this recall call 484-896-5688.

    Distribution

    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.

    Quantity

    5520 US, 40 OUS