BEUDAMED
    FDA Enforcement Class II Ongoing

    Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF FB462R, Glover ATR.CLAMP 210MM; (5) REF FB469R, Leland-Jones Peripheral CLMPSTR 195MM; (6) REF FB567R, Cooley Pediatric Clamp 30DG30/165MM; (7) REF FB568R, Cooley Pediatric Clamp 60DG 30/160MM; (8) REF FB569R, Cooley Pediatric Clamp 90DG30/150MM; (9) REF FB729R, Cooley Pediatric Clamp 17MM 170MM; (10) REF FB730R, Cooley Pediatric Clamp 20MM175MM; (11) REF FB736R, Cooley Pediatric Clamp 74MM 185MM; (12) REF FB737R, Cooley Pediatric Clamp 86MM 195MM; and (13) REF FB738R, Cooley Pediatric Clamp 108MM 260MM.

    Recall: Z-1311-2025 · Reported March 19, 2025

    Enforcement

    Recall Number
    Z-1311-2025
    Event ID
    96223
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aesculap Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 19, 2025
    Initiation Date
    January 31, 2025
    Classification Date
    March 11, 2025
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF FB462R, Glover ATR.CLAMP 210MM; (5) REF FB469R, Leland-Jones Peripheral CLMPSTR 195MM; (6) REF FB567R, Cooley Pediatric Clamp 30DG30/165MM; (7) REF FB568R, Cooley Pediatric Clamp 60DG 30/160MM; (8) REF FB569R, Cooley Pediatric Clamp 90DG30/150MM; (9) REF FB729R, Cooley Pediatric Clamp 17MM 170MM; (10) REF FB730R, Cooley Pediatric Clamp 20MM175MM; (11) REF FB736R, Cooley Pediatric Clamp 74MM 185MM; (12) REF FB737R, Cooley Pediatric Clamp 86MM 195MM; and (13) REF FB738R, Cooley Pediatric Clamp 108MM 260MM.

    Reason

    The forceps have been used in ways not covered by the design resulting in breakage of the clamps.

    Code Info

    GTIN numbers: (1) REF FB458R - 04038653156078; (2) REF FB459R - 04038653156085; (3) REF FB461R - 04038653156108; (4) REF FB462R - 04038653156115; (5) REF FB469R - 04038653156184; (6) REF FB567R - 04038653156948; (7) REF FB568R - 04038653156955; (8) REF FB569R - 04038653156962; (9) REF FB729R - 04038653157617; (10) REF FB730R - 04038653157624; (11) REF FB736R - 04038653157686; (12) REF FB737R - 04038653157693; and (13) REF FB738R - 04038653157709.

    Distribution

    Distribution was made nationwide and to PR. There was also government/military distribution. Foreign distribution was made to Canada, Bermuda, Bahamas, and Qatar.

    Quantity

    1,147 forceps