Z-3009-2024 Class II Ongoing

Recalled by MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL

Recall Details

Product Type
Devices
Report Date
September 18, 2024
Initiation Date
April 8, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Medline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O ; 2) GB GENERAL ENDO , Pack Number CDS984155F ; 3) ENDOSCOPY KIT , Pack Number DYKE1112 ; 4) ENDOSCOPY KIT , Pack Number DYKE1133A; 5) ENDOSCOPY PACK, Pack Number DYKE1264 ; 6) ENDOSCOPY KIT , Pack Number DYKE1389 ; 7) ENDO KIT, Pack Number DYKE1856 ; 8) WCH ENDO KIT, Pack Number DYKE1864B; 9) ENDO PACK , Pack Number DYNDA3058; 10) ENDOSCOPY PACK-LF , Pack Number DYNJ00339J ; 11) TR-ENT ENDO PACK-LF , Pack Number DYNJ0396027I ; 12) ENDOSCOPIC CHOLE PACK-LF, Pack Number DYNJ0426277J ; 13) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661L ; 14) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ22661O ; 15) ENDOSCOPY-LF, Pack Number DYNJ22890L ; 16) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G ; 17) ENDOSCOPY PACK, Pack Number DYNJ50594C ; 18) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221B ; 19) ABD ENDOSCOPIC PACK , Pack Number DYNJ54221C ; 20) ENDOSCOPIC PACK , Pack Number DYNJ54221J ; 21) CUSTOM ENDOSCOPY PACK-LF, Pack Number DYNJ55478B ; 22) CUSTOM ENDOSCOPY PACK-LF, Pack Number DYNJ55478D ; 23) ENDO PACK , Pack Number DYNJ56043B ; 24) ENDO PACK , Pack Number DYNJ56043C ; 25) ENDO PACK, Pack Number DYNJ56043F; 26) ENDO PACK , Pack Number DYNJ56043F ; 27) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648B ; 28) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648C ; 29) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648D ; 30) ENDOSCOPIC SKULL BASE , Pack Number DYNJ58648J ; 31) ENDO / AUG PACK , Pack Number DYNJ59250A ; 32) ENDO / AUG PACK , Pack Number DYNJ59250B ; 33) PACK ENDO AAA HYBRIDCHRG, Pack Number DYNJ60126B ; 34) DIPASCO GENERAL ENDOCRINE PACK, Pack Number DYNJ60686A ; 35) ENDOSCOPIC PACK , Pack Number DYNJ63797; 36) ENDOSCOPY PACK, Pack Number DYNJ65524; 37) GENERAL ENDOSCOPIC PK , Pack Number DYNJ66034A ; 38) ENT ENDO SINUS WILMINGTON PACK, Pack Number DYNJ66447; 39) ENDOVENOUS PACK , Pack Number DYNJ66596; 40) GENERAL ENDOSCOPIC PACK , Pack Number DYNJ67382B ; 41) PEDI ENDO LAP PACK, Pack Number DYNJ68141; 42) GEN ENDOSCOPY , Pack Number DYNJ81490; 43) PACK ENDOSCOPIC CHOLECYSTE, Pack Number DYNJ81539; 44) ENDO UROLOGY, Pack Number DYNJ83704A ; 45) ENDOSCOPY , Pack Number DYNJ900509N; 46) ENDOSCOPY , Pack Number DYNJ900509O; 47) ENDO OMH, Pack Number DYNJ900525C; 48) MODULE ENDO LAP , Pack Number DYNJ903026F; 49) MODULE ENDO LAP , Pack Number DYNJ903026G; 50) GENERAL ENDOSCOPY , Pack Number DYNJ903421D; 51) CYSTO , Pack Number DYNJ903521A; 52) GENERAL ENDOSCOPY , Pack Number DYNJ903826F; 53) ENDO, Pack Number DYNJ904836A; 54) ENDO, Pack Number DYNJ904836B; 55) ENDO, Pack Number DYNJ904836C; 56) ENDO, Pack Number DYNJ904836D; 57) DIPASCO GENERAL ENDOCRINE , Pack Number DYNJ906574 ; 58) ENDOSCOPIC SKULL BASE , Pack Number DYNJ908362B; 59) ENDOSCOPY KIT , Pack Number P830355A ; 60) ENDOSCOPY KIT , Pack Number P830355AH

Reason for Recall

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.

Distribution Pattern

Worldwide distribution.

Code Information

CDS981309O , Lot Number 19GBS426 ; CDS981309O , Lot Number 19JBE731 ; CDS981309O , Lot Number 19LBN327 ; CDS981309O , Lot Number 20BBE553 ; CDS981309O , Lot Number 20DBG947 ; CDS981309O , Lot Number 20GBU396 ; CDS984155F , Lot Number 19GBV870 ; CDS984155F , Lot Number 19JBX096 ; DYKE1112 , Lot Number 23LME611 ; DYKE1133A, Lot Number 22AMA243 ; DYKE1264 , Lot Number 22GME430 ; DYKE1264 , Lot Number 22HMA299 ; DYKE1389 , Lot Number 19DBL730 ; DYKE1389 , Lot Number 19DBN769 ; DYKE1389 , Lot Number 19VBA308 ; DYKE1389 , Lot Number 19KBI635 ; DYKE1389 , Lot Number 20ABU603 ; DYKE1856 , Lot Number 22JBU738 ; DYKE1856 , Lot Number 22LBC945 ; DYKE1856 , Lot Number 23ABJ226 ; DYKE1864B, Lot Number 23LBG919 ; DYNDA3058, Lot Number 23GBJ275 ; DYNDA3058, Lot Number 23JBJ971 ; DYNDA3058, Lot Number 23LBA980 ; DYNJ00339J , Lot Number 19LMB920 ; DYNJ00339J , Lot Number 20BMA093 ; DYNJ00339J , Lot Number 19DKA281 ; DYNJ00339J , Lot Number 19DKC903 ; DYNJ00339J , Lot Number 19GKA519 ; DYNJ00339J , Lot Number 19JKB148 ; DYNJ0396027I , Lot Number 19DDA509 ; DYNJ0426277J , Lot Number 19IMB754 ; DYNJ0426277J , Lot Number 20AMA124 ; DYNJ0426277J , Lot Number 20CMC692 ; DYNJ0426277J , Lot Number 20FMB816 ; DYNJ0426277J , Lot Number 20HMB568 ; DYNJ0426277J , Lot Number 20IMD473 ; DYNJ0426277J , Lot Number 21AMB951 ; DYNJ0426277J , Lot Number 21CMC718 ; DYNJ0426277J , Lot Number 21FMB061 ; DYNJ0426277J , Lot Number 19HKC356 ; DYNJ22661L , Lot Number 19HBO860 ; DYNJ22661L , Lot Number 19IBM436 ; DYNJ22661L , Lot Number 19JBQ066 ; DYNJ22661L , Lot Number 19KBK813 ; DYNJ22661L , Lot Number 19LBU575 ; DYNJ22661L , Lot Number 20BBX496 ; DYNJ22661L , Lot Number 20DBB020 ; DYNJ22661L , Lot Number 20GMC054 ; DYNJ22661L , Lot Number 20IMA806 ; DYNJ22661L , Lot Number 20IMC442 ; DYNJ22661L , Lot Number 20KMA517 ; DYNJ22661L , Lot Number 20LMF851 ; DYNJ22661L , Lot Number 21CMC664 ; DYNJ22661L , Lot Number 21HMA104 ; DYNJ22661L , Lot Number 21HMD574 ; DYNJ22661L , Lot Number 21IME853 ; DYNJ22661O , Lot Number 23GMB192 ; DYNJ22661O , Lot Number 23HMD182 ; DYNJ22661O , Lot Number 23IMG591 ; DYNJ22890L , Lot Number 19DBH535 ; DYNJ22890L , Lot Number 19EBT736 ; DYNJ22890L , Lot Number 19FBX264 ; DYNJ44673G , Lot Number 22IDB664 ; DYNJ44673G , Lot Number 22JDB619 ; DYNJ44673G , Lot Number 22KDB136 ; DYNJ44673G , Lot Number 22KDC145 ; DYNJ44673G , Lot Number 22LDA396 ; DYNJ44673G , Lot Number 23CDC115 ; DYNJ44673G , Lot Number 23DDB896 ; DYNJ44673G , Lot Number 23EDB560 ; DYNJ44673G , Lot Number 23GDB181 ; DYNJ44673G , Lot Number 23KDA313 ; DYNJ44673G , Lot Number 24ADA583 ; DYNJ44673G , Lot Number 24ADB767 ; DYNJ44673G , Lot Number 24BDB676 ; DYNJ50594C , Lot Number 19IBX922 ; DYNJ50594C , Lot Number 19JBY497 ; DYNJ50594C , Lot Number 20CBA891 ; DYNJ50594C , Lot Number 20DBQ243 ; DYNJ50594C , Lot Number 20EBR005 ; DYNJ50594C , Lot Number 20HBB011 ; DYNJ50594C , Lot Number 20HBM366 ; DYNJ50594C , Lot Number 21ABG167 ; DYNJ50594C , Lot Number 21BBN822 ; DYNJ50594C , Lot Number 21CBE742 ; DYNJ54221B , Lot Number 19RBA244 ; DYNJ54221B , Lot Number 19GBS216 ; DYNJ54221B , Lot Number 19HBJ331 ; DYNJ54221B , Lot Number 19HBL555 ; DYNJ54221C , Lot Number 19JBQ044 ; DYNJ54221C , Lot Number 19KBB653 ; DYNJ54221C , Lot Number 19LBS870 ; DYNJ54221C , Lot Number 20ABU331 ; DYNJ54221C , Lot Number 20BBL702 ; DYNJ54221C , Lot Number 20EBE847 ; DYNJ54221C , Lot Number 20EBK160 ; DYNJ54221J , Lot Number 23HBL781 ; DYNJ54221J , Lot Number 23JBW829 ; DYNJ54221J , Lot Number 23LBF338 ; DYNJ55478B , Lot Number 21GBP757 ; DYNJ55478B , Lot Number 21JBO286 ; DYNJ55478B , Lot Number 21JBO302 ; DYNJ55478B , Lot Number 21LBD900 ; DYNJ55478B , Lot Number 21LBS328 ; DYNJ55478B , Lot Number 22ABL817 ; DYNJ55478B , Lot Number 22ABU347 ; DYNJ55478B , Lot Number 19ABF658 ; DYNJ55478B , Lot Number 22BBT857 ; DYNJ55478B , Lot Number 19BBS313 ; DYNJ55478B , Lot Number 22OBG299 ; DYNJ55478B , Lot Number 22OBJ730 ; DYNJ55478B , Lot Number 22EBL784 ; DYNJ55478B , Lot Number 19EBA365 ; DYNJ55478B , Lot Number 19GBH857 ; DYNJ55478B , Lot Number 19HBL661 ; DYNJ55478B , Lot Number 19JBX017 ; DYNJ55478B , Lot Number 19LBG025 ; DYNJ55478B , Lot Number 20CBE081 ; DYNJ55478B , Lot Number 20CBM750 ; DYNJ55478B , Lot Number 20DBQ209 ; DYNJ55478B , Lot Number 20EBO179 ; DYNJ55478B , Lot Number 21EBP478 ; DYNJ55478B , Lot Number 21EBP489 ; DYNJ55478D , Lot Number 23DBH240 ; DYNJ55478D , Lot Number 23FBQ176 ; DYNJ55478D , Lot Number 23HBE122 ; DYNJ55478D , Lot Number 23IBT533 ; DYNJ55478D , Lot Number 23KBW864 ; DYNJ56043B , Lot Number 19FBW687 ; DYNJ56043B , Lot Number 19RBC753 ; DYNJ56043B , Lot Number 19HBD919 ; DYNJ56043C , Lot Number 19UBA723 ; DYNJ56043C , Lot Number 19KBS706 ; DYNJ56043C , Lot Number 19LBN154 ; DYNJ56043C , Lot Number 20BBR424 ; DYNJ56043C , Lot Number 20CBG391 ; DYNJ56043C , Lot Number 20EBH068 ; DYNJ56043C , Lot Number 20FBN679 ; DYNJ56043C , Lot Number 20HBB551 ; DYNJ56043C , Lot Number 20JBN241 ; DYNJ56043C , Lot Number 20KBK445 ; DYNJ56043F, Lot Number 24BMB676; DYNJ56043F , Lot Number 23JMA380 ; DYNJ56043F , Lot Number 23LMA604 ; DYNJ58648B , Lot Number 19BDB193 ; DYNJ58648C , Lot Number 19EDD585 ; DYNJ58648C , Lot Number 19IDA770 ; DYNJ58648C , Lot Number 20AMA033 ; DYNJ58648C , Lot Number 20AMC750 ; DYNJ58648C , Lot Number 20EMB449 ; DYNJ58648D , Lot Number 20KMC595 ; DYNJ58648D , Lot Number 21AMB129 ; DYNJ58648J , Lot Number 22KMD675 ; DYNJ58648J , Lot Number 23DMD129 ; DYNJ58648J , Lot Number 23HMG766 ; DYNJ58648J , Lot Number 23JMD938 ; DYNJ59250A , Lot Number 19IBG556 ; DYNJ59250A , Lot Number 19JBB091 ; DYNJ59250B , Lot Number 20ABS111 ; DYNJ59250B , Lot Number 20EBR009 ; DYNJ59250B , Lot Number 20FBA296 ; DYNJ59250B , Lot Number 20GMD049 ; DYNJ59250B , Lot Number 20HMD501 ; DYNJ59250B , Lot Number 20IMC499 ; DYNJ59250B , Lot Number 20JMD902 ; DYNJ59250B , Lot Number 20LMB819 ; DYNJ59250B , Lot Number 21AMD112 ; DYNJ59250B , Lot Number 21BMD535 ; DYNJ59250B , Lot Number 21CMB360 ; DYNJ59250B , Lot Number 21EMA212 ; DYNJ59250B , Lot Number 21FMA715 ; DYNJ60126B , Lot Number 22DMC817 ; DYNJ60126B , Lot Number 22FME975 ; DYNJ60126B , Lot Number 22IMG387 ; DYNJ60126B , Lot Number 22KMA517 ; DYNJ60126B , Lot Number 23BMC940 ; DYNJ60126B , Lot Number 23BMI394 ; DYNJ60126B , Lot Number 23CMF847 ; DYNJ60126B , Lot Number 23DMF461 ; DYNJ60126B , Lot Number 23EMF694 ; DYNJ60126B , Lot Number 23JMI216 ; DYNJ60126B , Lot Number 23KMF321 ; DYNJ60126B , Lot Number 23KMJ544 ; DYNJ60686A , Lot Number 19HBA763 ; DYNJ63797, Lot Number 19HBP133 ; DYNJ65524, Lot Number 20CBX808 ; DYNJ65524, Lot Number 20GBT243 ; DYNJ65524, Lot Number 20IBJ954 ; DYNJ65524, Lot Number 21ABP007 ; DYNJ66034A , Lot Number 22FBE056 ; DYNJ66034A , Lot Number 22HBT057 ; DYNJ66034A , Lot Number 22JBI274 ; DYNJ66034A , Lot Number 22JBY015 ; DYNJ66034A , Lot Number 22LBP732 ; DYNJ66034A , Lot Number 23ABL743 ; DYNJ66034A , Lot Number 23CBL351 ; DYNJ66034A , Lot Number 23CBW295 ; DYNJ66034A , Lot Number 23EBT384 ; DYNJ66034A , Lot Number 23EBT758 ; DYNJ66034A , Lot Number 23GBJ043 ; DYNJ66034A , Lot Number 23HBQ666 ; DYNJ66034A , Lot Number 23IBW230 ; DYNJ66034A , Lot Number 23JBX037 ; DYNJ66034A , Lot Number 23LBU935 ; DYNJ66447, Lot Number 21JBO555 ; DYNJ66447, Lot Number 21KBC098 ; DYNJ66447, Lot Number 21KBV126 ; DYNJ66447, Lot Number 21LBP144 ; DYNJ66447, Lot Number 22DBO407 ; DYNJ66447, Lot Number 22DBO928 ; DYNJ66447, Lot Number 22HBR972 ; DYNJ66447, Lot Number 22JBF016 ; DYNJ66447, Lot Number 23JBM687 ; DYNJ66447, Lot Number 23LBN206 ; DYNJ66596, Lot Number 20GBI925 ; DYNJ67382B , Lot Number 23EMF017 ; DYNJ67382B , Lot Number 23GMC927 ; DYNJ67382B , Lot Number 23HMC443 ; DYNJ67382B , Lot Number 23IME008 ; DYNJ67382B , Lot Number 23JMH559 ; DYNJ67382B , Lot Number 23LMC243 ; DYNJ68141, Lot Number 21CBK909 ; DYNJ68141, Lot Number 21DBJ222 ; DYNJ81490, Lot Number 22EBG821 ; DYNJ81490, Lot Number 22HBG106 ; DYNJ81490, Lot Number 22HBY318 ; DYNJ81490, Lot Number 22KBP817 ; DYNJ81490, Lot Number 23BBF609 ; DYNJ81539, Lot Number 22HBR010 ; DYNJ81539, Lot Number 22LBQ876 ; DYNJ81539, Lot Number 23ABU720 ; DYNJ81539, Lot Number 23CBI016 ; DYNJ83704A , Lot Number 23FMF339 ; DYNJ83704A , Lot Number 23HME942 ; DYNJ83704A , Lot Number 23HMF394 ; DYNJ83704A , Lot Number 23HMF701 ; DYNJ900509N, Lot Number 22JBW691 ; DYNJ900509N, Lot Number 22LBG812 ; DYNJ900509N, Lot Number 23ABM561 ; DYNJ900509N, Lot Number 23BBR703 ; DYNJ900509O, Lot Number 23FBK476 ; DYNJ900509O, Lot Number 23HBX994 ; DYNJ900509O, Lot Number 23IBN416 ; DYNJ900509O, Lot Number 23JBT820 ; DYNJ900509O, Lot Number 23KBP934 ; DYNJ900525C, Lot Number 19KBI868 ; DYNJ900525C, Lot Number 20BBI322 ; DYNJ900525C, Lot Number 20CBO862 ; DYNJ903026F, Lot Number 20BBK717 ; DYNJ903026F, Lot Number 20CBX723 ; DYNJ903026G, Lot Number 20DBT281 ; DYNJ903026G, Lot Number 20FBA151 ; DYNJ903026G, Lot Number 20FBT932 ; DYNJ903026G, Lot Number 20HBG899 ; DYNJ903026G, Lot Number 20IBS987 ; DYNJ903026G, Lot Number 20KBJ534 ; DYNJ903421D, Lot Number 19EBI945 ; DYNJ903421D, Lot Number 19FBN494 ; DYNJ903421D, Lot Number 19HBG628 ; DYNJ903421D, Lot Number 19HBM256 ; DYNJ903421D, Lot Number 19JBX085 ; DYNJ903421D, Lot Number 19LBB732 ; DYNJ903421D, Lot Number 20ABP122 ; DYNJ903421D, Lot Number 20CBC110 ; DYNJ903421D, Lot Number 20EBA325 ; DYNJ903421D, Lot Number 20FBG639 ; DYNJ903421D, Lot Number 20GBR856 ; DYNJ903421D, Lot Number 20IBB212 ; DYNJ903521A, Lot Number 19BBR865 ; DYNJ903521A, Lot Number 19CBT729 ; DYNJ903521A, Lot Number 19GBA961 ; DYNJ903521A, Lot Number 19VBE306 ; DYNJ903521A, Lot Number 20BBD187 ; DYNJ903826F, Lot Number 23ABJ844 ; DYNJ903826F, Lot Number 23ABS418 ; DYNJ903826F, Lot Number 23BBR653 ; DYNJ904836A, Lot Number 19CBF679 ; DYNJ904836A, Lot Number 19DBT189 ; DYNJ904836A, Lot Number 19FBM782 ; DYNJ904836A, Lot Number 19GBA138 ; DYNJ904836A, Lot Number 19IBA466 ; DYNJ904836A, Lot Number 19IBQ912 ; DYNJ904836A, Lot Number 19KBK072 ; DYNJ904836A, Lot Number 19LBP264 ; DYNJ904836A, Lot Number 20BBC548 ; DYNJ904836B, Lot Number 20ABM050 ; DYNJ904836B, Lot Number 20CBB774 ; DYNJ904836C, Lot Number 20CBU472 ; DYNJ904836D, Lot Number 20FBF337 ; DYNJ904836D, Lot Number 20IBD212 ; DYNJ904836D, Lot Number 20JBD003 ; DYNJ904836D, Lot Number 20JBD122 ; DYNJ904836D, Lot Number 20JBX884 ; DYNJ906574 , Lot Number 20CBH955 ; DYNJ906574 , Lot Number 20EBU071 ; DYNJ906574 , Lot Number 20FBB155 ; DYNJ906574 , Lot Number 20FBJ594 ; DYNJ906574 , Lot Number 20FBO709 ; DYNJ906574 , Lot Number 20FBP489 ; DYNJ906574 , Lot Number 20FBU277 ; DYNJ906574 , Lot Number 20GBB134 ; DYNJ906574 , Lot Number 20HBN043 ; DYNJ908362B, Lot Number 23FLA515 ; DYNJ908362B, Lot Number 23HLA926 ; DYNJ908362B, Lot Number 23ILA611 ; DYNJ908362B, Lot Number 23JLA551 ; DYNJ908362B, Lot Number 23KLA222 ; DYNJ908362B, Lot Number 23LLA801 ; P830355A , Lot Number 23LME416 ; P830355AH, Lot Number 23LME416