BEUDAMED
    FDA Recall Open, Classified

    Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 5) HSG TRAY, Pack Number DYNDH1453; 6) TRAY, ER LACERATION, Pack Number DYNDL1569A; 7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ; 8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ; 9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ; 10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ; 11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ; 12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ; 13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ; 14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ; 15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ; 16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ; 17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ; 18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ; 19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ; 20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ; 21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ; 22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ; 23) PELVISCOPY PACK , Pack Number DYNJ50688D ; 24) PELVISCOPY PACK , Pack Number DYNJ50688F ; 25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ; 26) PELVIC LAP, Pack Number DYNJ53601G ; 27) VAGINAL PACK, Pack Number DYNJ59786B ; 28) PELVIC PACK , Pack Number DYNJ63057D ; 29) PELVIC PACK , Pack Number DYNJ63057F ; 30) PERI GYN, Pack Number DYNJ64239B ; 31) OB GYN PACK , Pack Number DYNJ80831; 32) MON OB GYN PACK , Pack Number DYNJ80831A ; 33) MON OB GYN PACK , Pack Number DYNJ80831B ; 34) LAP PELVISCOPY PACK , Pack Number DYNJ82449; 35) PELVISCOPY PACK , Pack Number DYNJ82555; 36) PELVISCOPY PACK , Pack Number DYNJ82555A ; 37) PELVISCOPY, Pack Number DYNJ82676; 38) PERIPELVIC PACK , Pack Number DYNJ83912; 39) PELVISCOPY PACK , Pack Number DYNJ84379; 40) PELVISCOPY PACK , Pack Number DYNJ85311; 41) D-PELVISCOPY, Pack Number DYNJ900628I; 42) PELVISCOPY, Pack Number DYNJ901655F; 43) PELVISCOPY, Pack Number DYNJ901655G; 44) PELVISCOPY, Pack Number DYNJ908446B; 45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A; 46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B

    Recall: Z-3045-2024 · Initiated April 8, 2024

    Recall

    Recall Number
    Z-3045-2024
    Event Number
    94583
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    MLT
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    April 8, 2024
    Posted
    September 6, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline Convenience kits labeled as: 1) GROTH PELVISCOPY CDS, Pack Number CDS984187T ; 2) GROTH PELVISCOPY, Pack Number CDS984187U ; 3) DERMATOLOGY KIT, Pack Number DYNDA1567D; 4) ER MINOR SUTURE SET, Pack Number DYNDA1977A; 5) HSG TRAY, Pack Number DYNDH1453; 6) TRAY, ER LACERATION, Pack Number DYNDL1569A; 7) LAP/PELVISCOPY CSTM PK-LF , Pack Number DYNJ0157511K ; 8) SMSC-PELVISCOPY PACK-LF , Pack Number DYNJ0161619I ; 9) LAPAROSCOPY/PELVISCOPY PACK-LF, Pack Number DYNJ0477038K ; 10) LITHOTOMY/PELVISCOPY PACK , Pack Number DYNJ0531985R ; 11) GYN PELVISCOPY PACK-LF, Pack Number DYNJ0537705L ; 12) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009W ; 13) SM-PELVISCOPY PACK-LF , Pack Number DYNJ0780009Y ; 14) PELVISCOPY PACK-LF, Pack Number DYNJ0843760I ; 15) PELVISCOPY PACK-LF, Pack Number DYNJ0843760J ; 16) PELVISCOPY LAP-LF , Pack Number DYNJ40099B ; 17) PELVISCOPY LAP-LF , Pack Number DYNJ40099C ; 18) PELVISCOPY GYN LAP PACK , Pack Number DYNJ40608D ; 19) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595N ; 20) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595O ; 21) PELVISCOPY PACK (PVGSG)227, Pack Number DYNJ47595P ; 22) RFLAP PELVISCOPY PCK(LPLUH)-LF, Pack Number DYNJ47703G ; 23) PELVISCOPY PACK , Pack Number DYNJ50688D ; 24) PELVISCOPY PACK , Pack Number DYNJ50688F ; 25) HHI LITHOTOMY PELVISCOPY PACK , Pack Number DYNJ51918D ; 26) PELVIC LAP, Pack Number DYNJ53601G ; 27) VAGINAL PACK, Pack Number DYNJ59786B ; 28) PELVIC PACK , Pack Number DYNJ63057D ; 29) PELVIC PACK , Pack Number DYNJ63057F ; 30) PERI GYN, Pack Number DYNJ64239B ; 31) OB GYN PACK , Pack Number DYNJ80831; 32) MON OB GYN PACK , Pack Number DYNJ80831A ; 33) MON OB GYN PACK , Pack Number DYNJ80831B ; 34) LAP PELVISCOPY PACK , Pack Number DYNJ82449; 35) PELVISCOPY PACK , Pack Number DYNJ82555; 36) PELVISCOPY PACK , Pack Number DYNJ82555A ; 37) PELVISCOPY, Pack Number DYNJ82676; 38) PERIPELVIC PACK , Pack Number DYNJ83912; 39) PELVISCOPY PACK , Pack Number DYNJ84379; 40) PELVISCOPY PACK , Pack Number DYNJ85311; 41) D-PELVISCOPY, Pack Number DYNJ900628I; 42) PELVISCOPY, Pack Number DYNJ901655F; 43) PELVISCOPY, Pack Number DYNJ901655G; 44) PELVISCOPY, Pack Number DYNJ908446B; 45) NILES LAP PELVIC-LF , Pack Number DYNJ908459A; 46) NILES LAP PELVIC RFID-LF, Pack Number DYNJ908459B

    Reason

    Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

    Action

    Medline Industries LP issued a recall notice to its consignees on 04/08/2024 via letter delivered via USPS and email. The notice explained the issue, provided a link to for information pertaining to the risk involved https://www.fda.gov/medical-devices/safety-communications/update-evaluating-plastic-syringes-made-china-potential-device-failures-fda-safety-communication) and request these syringes within the convenience be discarded, except for circumstances where no alternative syringes are readily available. If these syringes must be used, closely monitor for leaks, breakage, and any other problems, and report any quality issues to Medline and the FDA. Distributors were directed to notify their customers. The firm issued a second recall notice (an expansion) on 05/02/2024 using the same methods.

    Distribution

    Worldwide distribution.