BEUDAMED
    FDA Recall Open, Classified

    Medline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6) LACERATION TRAY , Pack Number DYNDL1062B ; 7) LACERATION TRAY , Pack Number DYNDL1073; 8) LACERATION TRAY , Pack Number DYNDL1076; 9) LACERATION TRAY , Pack Number DYNDL1090A ; 10) ER LACERATION TRAY, Pack Number DYNDL1096; 11) LACERATION TRAY , Pack Number DYNDL1151C ; 12) LACERATION TRAY , Pack Number DYNDL1152A ; 13) LACERATION TRAY , Pack Number DYNDL1152AH; 14) LACERATION TRAY , Pack Number DYNDL1159B ; 15) LACERATION TRAY , Pack Number DYNDL1163; 16) LACERATION TRAY , Pack Number DYNDL1163H ; 17) LACERATION TRAY , Pack Number DYNDL1171; 18) CUSTOM LACERATION TRAY, Pack Number DYNDL1177C ; 19) E. R. LACERATION TRAY , Pack Number DYNDL1187A ; 20) LACERATION TRAY , Pack Number DYNDL1208B ; 21) LACERATION TRAY, Pack Number DYNDL1223A; 22) LACERATION TRAY , Pack Number DYNDL1250C ; 23) LACERATION TRAY , Pack Number DYNDL1257A ; 24) LACERATION TRAY , Pack Number DYNDL1263A ; 25) TRAY,LACERATION , Pack Number DYNDL1271B ; 26) LACERATION TRAY , Pack Number DYNDL1284; 27) LACERATION TRAY , Pack Number DYNDL1285; 28) LACERATION TRAY , Pack Number DYNDL1366A ; 29) LACERATION TRAY , Pack Number DYNDL1368; 30) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377A ; 31) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377AH; 32) LACERATION TRAY , Pack Number DYNDL1399; 33) LACERATION TRAY , Pack Number DYNDL1403; 34) LACERATION TRAY , Pack Number DYNDL1406A ; 35) TRAY,LACERATION , Pack Number DYNDL1455; 36) LACERATION TRAY , Pack Number DYNDL1457; 37) TRAY LACERATION , Pack Number DYNDL1465; 38) LACERATION TRAY , Pack Number DYNDL1496; 39) LACERATION TRAY , Pack Number DYNDL1496H ; 40) TRAY,LACERATION , Pack Number DYNDL1510; 41) TRAY,LACERATION, Pack Number DYNDL1542; 42) TRAY,LACERATION , Pack Number DYNDL1542; 43) TRAY ER LACERATION, Pack Number DYNDL1569A ; 44) TRAY SM ER LACERATION , Pack Number DYNDL1573; 45) LACERATION TRAY , Pack Number DYNDL1575A ; 46) LACERATION TRAY , Pack Number DYNDL1628A ; 47) LACERATION TRAY , Pack Number DYNDL1634; 48) LACERATION PACK , Pack Number DYNDL1637A ; 49) LACERATION TRAY , Pack Number DYNDL1678; 50) LACERATION TRAY , Pack Number DYNDL1679B ; 51) LACERATION TRAY , Pack Number DYNDL1690; 52) ER LACERATION TRAY, Pack Number DYNDL1693; 53) LACERATION TRAY , Pack Number DYNDL1705; 54) LACERATION TRAY, Pack Number DYNDL1705H ; 55) SUTURE LACERATION KIT , Pack Number DYNDL1707A ; 56) LACERATION TRAY , Pack Number DYNDL1714; 57) LACERATION KIT, Pack Number DYNDL1717; 58) NMG LACERATION TRAY , Pack Number DYNDL1722; 59) LACERATION TRAY , Pack Number DYNDL1728; 60) LACERATION TRAY , Pack Number DYNDL1729; 61) LACERATION TRAY , Pack Number DYNDL1739; 62) LACERATION TRAY , Pack Number DYNDL1740; 63) LACERATION TRAY , Pack Number DYNDL1757; 64) LACERATION TRAY , Pack Number DYNDL1758; 65) LACERATION TRAY, Pack Number DYNDL1758H ; 66) LACERATION TRAY HIGH GRADE, Pack Number DYNDL1762; 67) LACERATION TRAY , Pack Number DYNDL1768; 68) LACERATION TRAY , Pack Number DYNDL1770B ; 69) LACERATION TRAY , Pack Number DYNDL1772; 70) LACERATION TRAY , Pack Number DYNDL1774A ; 71) LACERATION TRAY W/SAFETY NDLS , Pack Number DYNDL1783; 72) LACERATION TRAY , Pack Number DYNDL1790; 73) LACERATION TRAY , Pack Number DYNDL1838; 74) LACERATION TRAY , Pack Number DYNDL1870; 75) LACERATION TRAY , Pack Number DYNDL1870H ; 76) LACERATION TRAY , Pack Number DYNDL1872; 77) LACERATION TRAY W/ UNDERPAD , Pack Number DYNDL1878; 78) LACERATION TRAY , Pack Number DYNDL1887; 79) LACERATION TRAY , Pack Number DYNDL1888; 80) LACERATION TRAY , Pack Number DYNDL1892; 81) LACERATION TRAY , Pack Number DYNDL1920; 82) LACERATION TRAY W/ ADSON FCP, Pack Number DYNDL1923A ; 83) LACERATION TRAY

    Recall: Z-3023-2024 · Initiated April 8, 2024

    Recall

    Recall Number
    Z-3023-2024
    Event Number
    94583
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    MCY
    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) CENTRAL LINE CDS, Pack Number CDS930092U ; 2) SMALL WOUND TRAY, Pack Number DYNDA1822; 3) RADIOLOGY UTILITY TRAY, Pack Number DYNDA2865; 4) BLOOD CULTURE SET , Pack Number DYNDH1495A ; 5) LACERATION TRAY , Pack Number DYNDL1050; 6) LACERATION TRAY , Pack Number DYNDL1062B ; 7) LACERATION TRAY , Pack Number DYNDL1073; 8) LACERATION TRAY , Pack Number DYNDL1076; 9) LACERATION TRAY , Pack Number DYNDL1090A ; 10) ER LACERATION TRAY, Pack Number DYNDL1096; 11) LACERATION TRAY , Pack Number DYNDL1151C ; 12) LACERATION TRAY , Pack Number DYNDL1152A ; 13) LACERATION TRAY , Pack Number DYNDL1152AH; 14) LACERATION TRAY , Pack Number DYNDL1159B ; 15) LACERATION TRAY , Pack Number DYNDL1163; 16) LACERATION TRAY , Pack Number DYNDL1163H ; 17) LACERATION TRAY , Pack Number DYNDL1171; 18) CUSTOM LACERATION TRAY, Pack Number DYNDL1177C ; 19) E. R. LACERATION TRAY , Pack Number DYNDL1187A ; 20) LACERATION TRAY , Pack Number DYNDL1208B ; 21) LACERATION TRAY, Pack Number DYNDL1223A; 22) LACERATION TRAY , Pack Number DYNDL1250C ; 23) LACERATION TRAY , Pack Number DYNDL1257A ; 24) LACERATION TRAY , Pack Number DYNDL1263A ; 25) TRAY,LACERATION , Pack Number DYNDL1271B ; 26) LACERATION TRAY , Pack Number DYNDL1284; 27) LACERATION TRAY , Pack Number DYNDL1285; 28) LACERATION TRAY , Pack Number DYNDL1366A ; 29) LACERATION TRAY , Pack Number DYNDL1368; 30) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377A ; 31) TRAY,FACIAL PLASTIC LACERATION, Pack Number DYNDL1377AH; 32) LACERATION TRAY , Pack Number DYNDL1399; 33) LACERATION TRAY , Pack Number DYNDL1403; 34) LACERATION TRAY , Pack Number DYNDL1406A ; 35) TRAY,LACERATION , Pack Number DYNDL1455; 36) LACERATION TRAY , Pack Number DYNDL1457; 37) TRAY LACERATION , Pack Number DYNDL1465; 38) LACERATION TRAY , Pack Number DYNDL1496; 39) LACERATION TRAY , Pack Number DYNDL1496H ; 40) TRAY,LACERATION , Pack Number DYNDL1510; 41) TRAY,LACERATION, Pack Number DYNDL1542; 42) TRAY,LACERATION , Pack Number DYNDL1542; 43) TRAY ER LACERATION, Pack Number DYNDL1569A ; 44) TRAY SM ER LACERATION , Pack Number DYNDL1573; 45) LACERATION TRAY , Pack Number DYNDL1575A ; 46) LACERATION TRAY , Pack Number DYNDL1628A ; 47) LACERATION TRAY , Pack Number DYNDL1634; 48) LACERATION PACK , Pack Number DYNDL1637A ; 49) LACERATION TRAY , Pack Number DYNDL1678; 50) LACERATION TRAY , Pack Number DYNDL1679B ; 51) LACERATION TRAY , Pack Number DYNDL1690; 52) ER LACERATION TRAY, Pack Number DYNDL1693; 53) LACERATION TRAY , Pack Number DYNDL1705; 54) LACERATION TRAY, Pack Number DYNDL1705H ; 55) SUTURE LACERATION KIT , Pack Number DYNDL1707A ; 56) LACERATION TRAY , Pack Number DYNDL1714; 57) LACERATION KIT, Pack Number DYNDL1717; 58) NMG LACERATION TRAY , Pack Number DYNDL1722; 59) LACERATION TRAY , Pack Number DYNDL1728; 60) LACERATION TRAY , Pack Number DYNDL1729; 61) LACERATION TRAY , Pack Number DYNDL1739; 62) LACERATION TRAY , Pack Number DYNDL1740; 63) LACERATION TRAY , Pack Number DYNDL1757; 64) LACERATION TRAY , Pack Number DYNDL1758; 65) LACERATION TRAY, Pack Number DYNDL1758H ; 66) LACERATION TRAY HIGH GRADE, Pack Number DYNDL1762; 67) LACERATION TRAY , Pack Number DYNDL1768; 68) LACERATION TRAY , Pack Number DYNDL1770B ; 69) LACERATION TRAY , Pack Number DYNDL1772; 70) LACERATION TRAY , Pack Number DYNDL1774A ; 71) LACERATION TRAY W/SAFETY NDLS , Pack Number DYNDL1783; 72) LACERATION TRAY , Pack Number DYNDL1790; 73) LACERATION TRAY , Pack Number DYNDL1838; 74) LACERATION TRAY , Pack Number DYNDL1870; 75) LACERATION TRAY , Pack Number DYNDL1870H ; 76) LACERATION TRAY , Pack Number DYNDL1872; 77) LACERATION TRAY W/ UNDERPAD , Pack Number DYNDL1878; 78) LACERATION TRAY , Pack Number DYNDL1887; 79) LACERATION TRAY , Pack Number DYNDL1888; 80) LACERATION TRAY , Pack Number DYNDL1892; 81) LACERATION TRAY , Pack Number DYNDL1920; 82) LACERATION TRAY W/ ADSON FCP, Pack Number DYNDL1923A ; 83) LACERATION TRAY

    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.