BEUDAMED
    FDA Recall Open, Classified

    Medline Convenience kits labeled as: 1) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS760053D ; 3) TUBAL LIGATION CDS, Pack Number CDS760053G ; 4) TUBAL LIGATION CDS, Pack Number CDS760053I ; 5) TUBAL LIGATION CDS, Pack Number CDS760053J ; 6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ; 7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ; 8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ; 9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ; 10) LIVER TRANSPLANT #57 CDS-2, Pack Number CDS860063R ; 11) GYN LAP , Pack Number CDS860087L ; 12) GYN LAPAROSCOPY CDS , Pack Number CDS860119Q ; 13) GYN LAPAROSCOPY CDS , Pack Number CDS860119R ; 14) GYN LAPAROSCOPY CDS , Pack Number CDS860119S ; 15) GYN LAPAROSCOPY CDS , Pack Number CDS860119U ; 16) GYN LAPAROSCOPY-LF, Pack Number CDS920074X ; 17) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099Q ; 18) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099R ; 19) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099S ; 20) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099SH; 21) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105D ; 22) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105F ; 23) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105I ; 24) GYN LAPAROSCOPY CDS , Pack Number CDS920124J ; 25) LAVH CDS, Pack Number CDS920130J ; 26) GYN LAPAROSCOPY CDS , Pack Number CDS930198S ; 27) GYN LAPAROSCOPY CDS , Pack Number CDS930198T ; 28) GYN LAPAROSCOPY CDS , Pack Number CDS930198U ; 29) GYN LAPAROSCOPY CDS , Pack Number CDS930198V ; 30) GYN LAPAROSCOPY CDS , Pack Number CDS930198W ; 31) GYN LAPAROSCOPY CDS , Pack Number CDS930198X ; 32) GYN LAPAROSCOPIC, Pack Number CDS930224I ; 33) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258S ; 34) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258T ; 35) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258U ; 36) ROBOTIC , Pack Number CDS980523M ; 37) ROBOTIC GYN , Pack Number CDS980647K ; 38) GYN LAP PROCEDURE , Pack Number CDS980810O ; 39) GYN LAP PROCEDURE , Pack Number CDS980810P ; 40) GYN LAP PROCEDURE , Pack Number CDS980810Q ; 41) GYN LAPAROSCOPY , Pack Number CDS980843G ; 42) GYN LAPAROSCOPY , Pack Number CDS980843I ; 43) DAVINCI PROCEDURE , Pack Number CDS980864O ; 44) DAVINCI PROCEDURE , Pack Number CDS980864P ; 45) GYN MAJOR CDS , Pack Number CDS980998J ; 46) GYN MAJOR , Pack Number CDS980998L ; 47) GYN ENDOSCOPY KIT , Pack Number CDS981309P ; 48) GYN ENDOSCOPY KIT , Pack Number CDS981309Q ; 49) GYN ENDOSCOPY KIT , Pack Number CDS981309T ; 50) PELVISCOPY CDS, Pack Number CDS981546F ; 51) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583R ; 52) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583S ; 53) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583T ; 54) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583U ; 55) GYN DAVINCI CDS , Pack Number CDS981606F ; 56) ROBOTIC PACK-LF , Pack Number CDS981757Q ; 57) GYN LAPAROSCOPY CDS , Pack Number CDS981880R ; 58) GYN LAPAROSCOPY CDS , Pack Number CDS981880S ; 59) GYN LAPAROSCOPY CDS , Pack Number CDS981880T ; 60) GYN LAPAROSCOPY CDS , Pack Number CDS981880U ; 61) GYN LAPAROSCOPY CDS , Pack Number CDS981880V ; 62) GYN LAPAROSCOPY CDS , Pack Number CDS981880W ; 63) GYN LAPAROSCOPY CDS , Pack Number CDS981880X ; 64) ROBOTIC CDS , Pack Number CDS981882W ; 65) ROBOTIC CDS , Pack Number CDS981882X ; 66) LITHOTOMY CDS , Pack Number CDS981897S ; 67) LITHOTOMY CDS , Pack Number CDS981897T ; 68) GYN LAPAROSCOPY CDS-LF, Pack Number CDS981988I ; 69) GYN LAPAROSCOPY , Pack Number CDS982032U ; 70) GYN LAPAROSCOPY , Pack Number CDS982032V ; 71) GYN LAPAROSCOPY , Pack Number CDS982032W ; 72) GYN LAPAROSCOPY , Pack Number CDS982032X ; 73) GYN LAPAROSCOPY , Pack Number CDS982032Y ; 74) ROBOTIC , Pack Number CDS982046V ; 75) ROBOTIC MAJOR , Pack Number CDS982046X ; 76) ROBOTIC MAJOR , Pack Number CDS982046Y ; 77) LIVER PROCEDURE , Pack Number CDS982106J ; 78) ROBOTIC PROCEDURE , Pack Number CDS982128P ; 79) GYN LAPAROSCOPY CDS , Pack Number CDS982245K ; 80

    Recall: Z-3046-2024 · Initiated April 8, 2024

    Recall

    Recall Number
    Z-3046-2024
    Event Number
    94583
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    OHD
    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) LAVH CDS, Pack Number CDS760049AB; 2) TUBAL LIGATION CDS, Pack Number CDS760053D ; 3) TUBAL LIGATION CDS, Pack Number CDS760053G ; 4) TUBAL LIGATION CDS, Pack Number CDS760053I ; 5) TUBAL LIGATION CDS, Pack Number CDS760053J ; 6) GYN LAPAROSCOPY-LF, Pack Number CDS760059F ; 7) GYN LAPAROSCOPY-LF, Pack Number CDS760059G ; 8) GYN LAPAROSCOPY-LF, Pack Number CDS760059I ; 9) GYN LAPAROSCOPY-LF, Pack Number CDS760059J ; 10) LIVER TRANSPLANT #57 CDS-2, Pack Number CDS860063R ; 11) GYN LAP , Pack Number CDS860087L ; 12) GYN LAPAROSCOPY CDS , Pack Number CDS860119Q ; 13) GYN LAPAROSCOPY CDS , Pack Number CDS860119R ; 14) GYN LAPAROSCOPY CDS , Pack Number CDS860119S ; 15) GYN LAPAROSCOPY CDS , Pack Number CDS860119U ; 16) GYN LAPAROSCOPY-LF, Pack Number CDS920074X ; 17) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099Q ; 18) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099R ; 19) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099S ; 20) GYN LAPAROSCOPY CDS #34-RF, Pack Number CDS920099SH; 21) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105D ; 22) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105F ; 23) GYN LAPAROSCOPY CDS-LF, Pack Number CDS920105I ; 24) GYN LAPAROSCOPY CDS , Pack Number CDS920124J ; 25) LAVH CDS, Pack Number CDS920130J ; 26) GYN LAPAROSCOPY CDS , Pack Number CDS930198S ; 27) GYN LAPAROSCOPY CDS , Pack Number CDS930198T ; 28) GYN LAPAROSCOPY CDS , Pack Number CDS930198U ; 29) GYN LAPAROSCOPY CDS , Pack Number CDS930198V ; 30) GYN LAPAROSCOPY CDS , Pack Number CDS930198W ; 31) GYN LAPAROSCOPY CDS , Pack Number CDS930198X ; 32) GYN LAPAROSCOPIC, Pack Number CDS930224I ; 33) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258S ; 34) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258T ; 35) GYN LAPAROSCOPY PROCEDURE-LF, Pack Number CDS980258U ; 36) ROBOTIC , Pack Number CDS980523M ; 37) ROBOTIC GYN , Pack Number CDS980647K ; 38) GYN LAP PROCEDURE , Pack Number CDS980810O ; 39) GYN LAP PROCEDURE , Pack Number CDS980810P ; 40) GYN LAP PROCEDURE , Pack Number CDS980810Q ; 41) GYN LAPAROSCOPY , Pack Number CDS980843G ; 42) GYN LAPAROSCOPY , Pack Number CDS980843I ; 43) DAVINCI PROCEDURE , Pack Number CDS980864O ; 44) DAVINCI PROCEDURE , Pack Number CDS980864P ; 45) GYN MAJOR CDS , Pack Number CDS980998J ; 46) GYN MAJOR , Pack Number CDS980998L ; 47) GYN ENDOSCOPY KIT , Pack Number CDS981309P ; 48) GYN ENDOSCOPY KIT , Pack Number CDS981309Q ; 49) GYN ENDOSCOPY KIT , Pack Number CDS981309T ; 50) PELVISCOPY CDS, Pack Number CDS981546F ; 51) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583R ; 52) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583S ; 53) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583T ; 54) GYN-URO LAPSCP CDS-LF , Pack Number CDS981583U ; 55) GYN DAVINCI CDS , Pack Number CDS981606F ; 56) ROBOTIC PACK-LF , Pack Number CDS981757Q ; 57) GYN LAPAROSCOPY CDS , Pack Number CDS981880R ; 58) GYN LAPAROSCOPY CDS , Pack Number CDS981880S ; 59) GYN LAPAROSCOPY CDS , Pack Number CDS981880T ; 60) GYN LAPAROSCOPY CDS , Pack Number CDS981880U ; 61) GYN LAPAROSCOPY CDS , Pack Number CDS981880V ; 62) GYN LAPAROSCOPY CDS , Pack Number CDS981880W ; 63) GYN LAPAROSCOPY CDS , Pack Number CDS981880X ; 64) ROBOTIC CDS , Pack Number CDS981882W ; 65) ROBOTIC CDS , Pack Number CDS981882X ; 66) LITHOTOMY CDS , Pack Number CDS981897S ; 67) LITHOTOMY CDS , Pack Number CDS981897T ; 68) GYN LAPAROSCOPY CDS-LF, Pack Number CDS981988I ; 69) GYN LAPAROSCOPY , Pack Number CDS982032U ; 70) GYN LAPAROSCOPY , Pack Number CDS982032V ; 71) GYN LAPAROSCOPY , Pack Number CDS982032W ; 72) GYN LAPAROSCOPY , Pack Number CDS982032X ; 73) GYN LAPAROSCOPY , Pack Number CDS982032Y ; 74) ROBOTIC , Pack Number CDS982046V ; 75) ROBOTIC MAJOR , Pack Number CDS982046X ; 76) ROBOTIC MAJOR , Pack Number CDS982046Y ; 77) LIVER PROCEDURE , Pack Number CDS982106J ; 78) ROBOTIC PROCEDURE , Pack Number CDS982128P ; 79) GYN LAPAROSCOPY CDS , Pack Number CDS982245K ; 80

    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.