BEUDAMED
    FDA Recall Open, Classified

    1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;

    Recall: Z-3164-2024 · Initiated June 25, 2024

    Recall

    Recall Number
    Z-3164-2024
    Event Number
    95133
    Firm
    UNIMAX MEDICAL SYSTEMS INC 8F-2, NO
    FEI Number
    3007791595
    Product Code
    GCJ
    Status
    Open, Classified
    Root Cause
    Device Design
    Initiated
    June 25, 2024
    Posted
    September 17, 2024
    Address
    127 LANE 235, PAO CHIAO RD, Hsin Tien Taiwan

    Description

    1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10", sterile; 4. UNIMAX Detachable endo pocket, REF FEP936116, 3" x 6", sterile; 5. UNIMAX Detachable endo pocket, REF FEP979000, 8" x 10", sterile; 6. ConMed Corporation Detachable endo pocket, REF SB936, 3" x 6", sterile; 7. ConMed Corporation Detachable endo pocket, REF SB957, 5" x 7", sterile; 8. ConMed Corporation Detachable endo pocket, REF SB979, 7.5" x 9", sterile; 9. ConMed Corporation Detachable endo pocket, REF SB979-CA, 7.5 x 9", sterile; 10. ConMed Corporation Detachable endo pocket, REF SB936-CA, 3" x 6", sterile;

    Reason

    The tube may fall into the surgical site during the grasping process.

    Action

    The recalling firm issued letters dated 6/25/2024 to two distributors and dated 6/27/2024 to one distributor. The letters were issued via email beginning 6/25/2024. The letter provided the reason for recall and the actions to be taken, which included: (1) Identify the affected devices at your facility and complete the Acknowledgement and Receipt Form; (2) Distribute the notification to relevant people/facilities to where the affected lots have been distributed. (3) Quarantine the affected devices and implement the destruction after receiving confirmation from UNIMAX. A list of catalog numbers and lot numbers was enclosed. If the consignee had the affected product, they were to list the catalog number, lot number, and quantity in their possession on the Acknowledgement and Receipt Form. They were to also indicate whether they have notified the relevant person/facility to where the affected lot had been distributed and indicate they have quarantined the affected devices for destruction. The form was to be emailed to the recalling firm.

    Distribution

    US Nationwide distribution in the states of GA, MO, and PA.

    Quantity

    81,241 endo retrieval pouches