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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmApril 08, 2024
Date PostedSeptember 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3050-2024
Recall Event ID 94583
Product Classification Obstetrical kit - Product Code OKV
ProductMedline Convenience kits labeled as: 1) LABOR & DELIVERY CDS, Pack Number CDS830039AD; 2) FETAL SURGERY CDS-LF, Pack Number CDS840214P ; 3) OB PROCEDURE-LF , Pack Number CDS981335C ; 4) ROBOTIC PACK-LF , Pack Number CDS981757P ; 5) GYN ROBOTIC , Pack Number CDS981826J ; 6) ROBOTIC CDS , Pack Number CDS981882Q ; 7) ROBOTIC CDS , Pack Number CDS981882R ; 8) ROBOTIC UROLOGY CDS , Pack Number CDS981984I ; 9) D&C CDS-WRMC, Pack Number CDS982331N ; 10) LITHOTOMY CDS-WRMC, Pack Number CDS982333O ; 11) LITHOTOMY CDS-WRMC, Pack Number CDS982333P ; 12) DEPAUL DAVINCI CDS, Pack Number CDS982377G ; 13) BAP NORTH BASIC MINOR GYN CDS , Pack Number CDS982397B ; 14) BAP NORTH ROBOTIC SURGERY CDS , Pack Number CDS982407N ; 15) GYN/ABDOMINAL , Pack Number CDS982725M ; 16) ROBOTIC CDS , Pack Number CDS982888D ; 17) ROBOTIC CDS , Pack Number CDS982888F ; 18) ROBOTIC CDS , Pack Number CDS982888G ; 19) ROBOTIC CDS , Pack Number CDS983028D ; 20) ZALE PUMP CDS , Pack Number CDS983187F ; 21) CUH UROLOGY ROBOTIC CDS , Pack Number CDS983190L ; 22) ROBOTIC PROSTATECTOMY CDS , Pack Number CDS983216I ; 23) ROBOTIC CDS-LF, Pack Number CDS983258O ; 24) ROBOTIC CDS-LF, Pack Number CDS983258Q ; 25) VAGINAL MINOR , Pack Number CDS983268K ; 26) CUH GEN/GYN ROBOTIC CDS , Pack Number CDS983375K ; 27) ROBOTIC CDS , Pack Number CDS983399D ; 28) GYN VAGINAL CDS , Pack Number CDS983528L ; 29) GYN VAGINAL CDS , Pack Number CDS983528M ; 30) CELEBRATION ROBOTIC CDS , Pack Number CDS983612C ; 31) DAVINCI PROSTATECTOMY CDS , Pack Number CDS983667F ; 32) ROBOTIC LAP NISSEN CDS, Pack Number CDS983687F ; 33) OB CDS, Pack Number CDS983854B ; 34) OB/GYN CDS, Pack Number CDS984173F ; 35) GROTH VAGINAL , Pack Number CDS984201V ; 36) ROBOTIC LITHOTOMY , Pack Number CDS984454N ; 37) DAVINCI ROBOTIC CDS , Pack Number CDS984463C ; 38) DAVINCI CDS UCC-LF, Pack Number CDS984663G ; 39) GYN CDS , Pack Number CDS984860G ; 40) OB DELIVERY CDS , Pack Number CDS985027I ; 41) OB/GYN CDS RICE , Pack Number CDS985256C ; 42) OB/GYN CDS RICE , Pack Number CDS985256D ; 43) OB/GYN CDS RICE , Pack Number CDS985256F ; 44) OB CDS-LF , Pack Number CDS985320C ; 45) OB, Pack Number CDS985506D ; 46) OB, Pack Number CDS985506F ; 47) OB, Pack Number CDS985506G ; 48) OB, Pack Number CDS985506I ; 49) GYN LAPAROSCOPY , Pack Number CDS985519L ; 50) KIT ROBOTICS GYN, Pack Number DYKMBNDL109A ; 51) TRAY HYSTEROSALPINGOGRAM, Pack Number DYNDE1010A ; 52) PERI-GYN PACK-LF, Pack Number DYNJ0038057; 53) ROBOTICS PACK-LF, Pack Number DYNJ0038258B ; 54) DAVINCI PACK-LF , Pack Number DYNJ0042750; 55) ROBOTICS PACK-LF, Pack Number DYNJ0046667A ; 56) ROBOTIC PACK-LF , Pack Number DYNJ0048814I ; 57) NILES LAP PELVIC PACK-LF, Pack Number DYNJ0101440F ; 58) OB DELIVERY PACK-LF , Pack Number DYNJ0103039B ; 59) D AND C PACK-LF , Pack Number DYNJ0161028C ; 60) D AND C PACK-LF , Pack Number DYNJ0161028F ; 61) D AND C PACK-LF , Pack Number DYNJ0161028G ; 62) PELVISCOPY (SMSC) PACK-LF , Pack Number DYNJ0161619D ; 63) LAP SUPRA CERVICAL PACK-LF, Pack Number DYNJ0161811C ; 64) ROBOT PACK, Pack Number DYNJ01823F ; 65) ROBOTICS PACK-LF, Pack Number DYNJ0193529A ; 66) DELIVERY ROOM PACK-LF , Pack Number DYNJ0287784R ; 67) OB PACK , Pack Number DYNJ03387A ; 68) PERI GYN PACK-LF, Pack Number DYNJ0362432L ; 69) PERI GYN PACK-LF, Pack Number DYNJ0362432M ; 70) OB PACK-LF, Pack Number DYNJ0367126L ; 71) OB PACK-LF, Pack Number DYNJ0367126M ; 72) OB PACK-LF, Pack Number DYNJ0367126N ; 73) BIRTHING PACK-LF, Pack Number DYNJ0367360K ; 74) BIRTHING PACK-LF, Pack Number DYNJ0367360L ; 75) OB DELIVERY PACK-LF , Pack Number DYNJ0374609J ; 76) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378293K ; 77) ANTERIOR CERVICAL PACK-LF , Pack Number DYNJ0378634F ; 78) GENERAL MATERNITY PACK-LF , Pack Number DYNJ0382586I ; 79) ANT CERVICAL DISKECT PACK-LF, Pack Number DYNJ0399835M ; 80) BIRTHING PACK-LF, Pack Number DYNJ0409968D ; 81) AOP/VAGINAL MAJOR PACK-LF , Pack Number DYNJ
Code Information CDS830039AD, Lot Number 19CBH292 ; CDS830039AD, Lot Number 19PBC608 ; CDS840214P , Lot Number 21FBN852 ; CDS840214P , Lot Number 21HBB376 ; CDS840214P , Lot Number 21HBF491 ; CDS840214P , Lot Number 21IBO111 ; CDS840214P , Lot Number 22ABD314 ; CDS840214P , Lot Number 22BBI956 ; CDS840214P , Lot Number 22HBP289 ; CDS840214P , Lot Number 22IBO308 ; CDS840214P , Lot Number 22IBR971 ; CDS840214P , Lot Number 22KBN497 ; CDS840214P , Lot Number 20JBQ048 ; CDS840214P , Lot Number 20KBG189 ; CDS840214P , Lot Number 20KBY177 ; CDS840214P , Lot Number 21BBC946 ; CDS981335C , Lot Number 21GBL170 ; CDS981335C , Lot Number 21HBB530 ; CDS981335C , Lot Number 21WBA896 ; CDS981335C , Lot Number 22NBC853 ; CDS981335C , Lot Number 22OBB104 ; CDS981335C , Lot Number 22IBP869 ; CDS981335C , Lot Number 20GBI170 ; CDS981335C , Lot Number 20KBR144 ; CDS981335C , Lot Number 21BBE035 ; CDS981335C , Lot Number 21BBL646 ; CDS981335C , Lot Number 21EBH220 ; CDS981757P , Lot Number 21FMB526 ; CDS981757P , Lot Number 21FMD778 ; CDS981757P , Lot Number 21GMB729 ; CDS981757P , Lot Number 21HMF534 ; CDS981757P , Lot Number 21KMD539 ; CDS981757P , Lot Number 21LMC014 ; CDS981757P , Lot Number 22AMF312 ; CDS981757P , Lot Number 20HKC001 ; CDS981757P , Lot Number 20LKA498 ; CDS981757P , Lot Number 21DKA317 ; CDS981757P , Lot Number 21EKA037 ; CDS981826J , Lot Number 21FBR364 ; CDS981826J , Lot Number 21IBE988 ; CDS981826J , Lot Number 21VBB532 ; CDS981826J , Lot Number 21LBO570 ; CDS981826J , Lot Number 21LBO574 ; CDS981826J , Lot Number 22CBA147 ; CDS981826J , Lot Number 19ABX512 ; CDS981826J , Lot Number 19CBO432 ; CDS981826J , Lot Number 22DBM116 ; CDS981826J , Lot Number 22EBB425 ; CDS981826J , Lot Number 19EBK468 ; CDS981826J , Lot Number 22GBU016 ; CDS981826J , Lot Number 19FBW726 ; CDS981826J , Lot Number 22HBN374 ; CDS981826J , Lot Number 22IBA569 ; CDS981826J , Lot Number 19HBD972 ; CDS981826J , Lot Number 22JBI776 ; CDS981826J , Lot Number 19IBD508 ; CDS981826J , Lot Number 22KBD576 ; CDS981826J , Lot Number 19IBP473 ; CDS981826J , Lot Number 22LBM177 ; CDS981826J , Lot Number 23ABL468 ; CDS981826J , Lot Number 19KBT872 ; CDS981826J , Lot Number 19LBY107 ; CDS981826J , Lot Number 23DBT137 ; CDS981826J , Lot Number 23EBK904 ; CDS981826J , Lot Number 23EBW563 ; CDS981826J , Lot Number 20BBQ533 ; CDS981826J , Lot Number 23FBL903 ; CDS981826J , Lot Number 20CBC257 ; CDS981826J , Lot Number 23GBP568 ; CDS981826J , Lot Number 20FBA574 ; CDS981826J , Lot Number 23IBU308 ; CDS981826J , Lot Number 23IBW118 ; CDS981826J , Lot Number 23KBL301 ; CDS981826J , Lot Number 20HBU183 ; CDS981826J , Lot Number 24CBA387 ; CDS981826J , Lot Number 24CBG312 ; CDS981826J , Lot Number 20KBT694 ; CDS981826J , Lot Number 20LBR755 ; CDS981826J , Lot Number 20LBU444 ; CDS981826J , Lot Number 21BBD223 ; CDS981826J , Lot Number 21BBR536 ; CDS981826J , Lot Number 21CBO855 ; CDS981826J , Lot Number 21CBR551 ; CDS981882Q , Lot Number 19PBB582 ; CDS981882Q , Lot Number 19GBP429 ; CDS981882Q , Lot Number 19HBR905 ; CDS981882Q , Lot Number 19JBQ808 ; CDS981882R , Lot Number 19JBS122 ; CDS981882R , Lot Number 19LBF118 ; CDS981984I , Lot Number 21IBP860 ; CDS981984I , Lot Number 21KBD858 ; CDS981984I , Lot Number 19BBK784 ; CDS981984I , Lot Number 19BBR887 ; CDS981984I , Lot Number 19CBI615 ; CDS981984I , Lot Number 22OBI060 ; CDS981984I , Lot Number 19EBQ351 ; CDS981984I , Lot Number 22HBF738 ; CDS981984I , Lot Number 22IBN140 ; CDS981984I , Lot Number 19HBK974 ; CDS981984I , Lot Number 22JBP284 ; CDS981984I , Lot Number 22KBF154 ; CDS981984I , Lot Number 23ABH884 ; CDS981984I , Lot Number 23ABT088 ; CDS981984I , Lot Number 23BBU118 ; CDS981984I , Lot Number 23BBU913 ; CDS981984I , Lot Number 23CBM167 ; CDS981984I , Lot Number 20ABG963 ; CDS981984I , Lot Number 23EBN576 ; CDS981984I , Lot Number 20BBI298 ; CDS981984I , Lot Number 23GBW025 ; CDS981984I , Lot Number 20DBG987 ; CDS981984I , Lot Number 20EBO956 ; CDS981984I , Lot Number 23KBK041 ; CDS981984I , Lot Number 23LBD384 ; CDS981984I , Lot Number 20JBR239 ; CDS981984I , Lot Number 20KBU642 ; CDS981984I , Lot Number 20LBP817 ; CDS981984I , Lot Number 21BBB755 ; CDS981984I , Lot Number 21CBE512 ; CDS981984I , Lot Number 21DBI758 ; CDS981984I , Lot Number 21DBY148 ; CDS981984I , Lot Number 22CLA775 ; CDS982331N , Lot Number 23FBO186 ; CDS982331N , Lot Number 23IBT119 ; CDS982331N , Lot Number 23JBW645 ; CDS982331N , Lot Number 23KBP687 ; CDS982331N , Lot Number 24ABM130 ; CDS982333O , Lot Number 23GBT894 ; CDS982333O , Lot Number 23IBQ626 ; CDS982333O , Lot Number 23JBF455 ; CDS982333P , Lot Number 23KBP662 ; CDS982333P , Lot Number 23LBS967 ; CDS982377G , Lot Number 19ABR698 ; CDS982377G , Lot Number 19BBS890 ; CDS982397B , Lot Number 21GBC711 ; CDS982397B , Lot Number 21HBE154 ; CDS982397B , Lot Number 21JBI916 ; CDS982397B , Lot Number 19BBM033 ; CDS982397B , Lot Number 19CBH369 ; CDS982397B , Lot Number 19DBL294 ; CDS982397B , Lot Number 19DBV544 ; CDS982397B , Lot Number 19EBR006 ; CDS982397B , Lot Number 19FBZ758 ; CDS982397B , Lot Number 19SBG230 ; CDS982397B , Lot Number 19HBN857 ; CDS982397B , Lot Number 19JBT821 ; CDS982397B , Lot Number 19LBO309 ; CDS982397B , Lot Number 20ABN427 ; CDS982397B , Lot Number 20BBE609 ; CDS982397B , Lot Number 20EBV316 ; CDS982397B , Lot Number 20GBU953 ; CDS982397B , Lot Number 20KBQ006 ; CDS982397B , Lot Number 21ABS087 ; CDS982397B , Lot Number 21CBY314 ; CDS982397B , Lot Number 21EBA181 ; CDS982407N , Lot Number 21HBR933 ; CDS982407N , Lot Number 21IBA124 ; CDS982407N , Lot Number 19FBE601 ; CDS982407N , Lot Number 19GBR812 ; CDS982407N , Lot Number 19HBY614 ; CDS982407N , Lot Number 19IBP675 ; CDS982407N , Lot Number 19JBR316 ; CDS982407N , Lot Number 19VBA672 ; CDS982407N , Lot Number 20CBX761 ; CDS982407N , Lot Number 20DBV869 ; CDS982407N , Lot Number 20FBB987 ; CDS982407N , Lot Number 20GBD747 ; CDS982407N , Lot Number 20GBQ181 ; CDS982407N , Lot Number 20HBG094 ; CDS982407N , Lot Number 20IBO544 ; CDS982407N , Lot Number 20IBO700 ; CDS982407N , Lot Number 20KBH410 ; CDS982407N , Lot Number 20KBJ015 ; CDS982407N , Lot Number 21CBD150 ; CDS982407N , Lot Number 21DBO201 ; CDS982407N , Lot Number 21FBH136 ; CDS982725M , Lot Number 21FBI678 ; CDS982725M , Lot Number 21HBA025 ; CDS982725M , Lot Number 21HBT649 ; CDS982725M , Lot Number 21JBX792 ; CDS982725M , Lot Number 22BBL928 ; CDS982725M , Lot Number 22FBB426 ; CDS982725M , Lot Number 22HBF739 ; CDS982888D , Lot Number 19ABH707 ; CDS982888F , Lot Number 19BBC785 ; CDS982888F , Lot Number 19BBR212 ; CDS982888F , Lot Number 19PBB698 ; CDS982888F , Lot Number 19PBC886 ; CDS982888F , Lot Number 19QBB894 ; CDS982888G , Lot Number 19HBP405 ; CDS982888G , Lot Number 19HBT021 ; CDS982888G , Lot Number 19TBB421 ; CDS982888G , Lot Number 19IBV342 ; CDS982888G , Lot Number 19KBA176 ; CDS982888G , Lot Number 19KBZ824 ; CDS983028D , Lot Number 19ABH844 ; CDS983028D , Lot Number 19BBO280 ; CDS983028D , Lot Number 19CBN005 ; CDS983028D , Lot Number 19PBB799 ; CDS983028D , Lot Number 19FBT105 ; CDS983028D , Lot Number 19IBA387 ; CDS983187F , Lot Number 21IBJ817 ; CDS983187F , Lot Number 21IBP797 ; CDS983187F , Lot Number 21IBP798 ; CDS983187F , Lot Number 21KBA432 ; CDS983187F , Lot Number 21LBV084 ; CDS983187F , Lot Number 22BBA316 ; CDS983187F , Lot Number 19CBF206 ; CDS983187F , Lot Number 19DBJ632 ; CDS983187F , Lot Number 22EBM612 ; CDS983187F , Lot Number 22EBQ486 ; CDS983187F , Lot Number 19EBM749 ; CDS983187F , Lot Number 19FBO257 ; CDS983187F , Lot Number 22HBS845 ; CDS983187F , Lot Number 22IBD862 ; CDS983187F , Lot Number 22JBA824 ; CDS983187F , Lot Number 19HBZ088 ; CDS983187F , Lot Number 19IBD306 ; CDS983187F , Lot Number 19JBT686 ; CDS983187F , Lot Number 20ABL838 ; CDS983187F , Lot Number 20CBB783 ; CDS983187F , Lot Number 20CBF497 ; CDS983187F , Lot Number 20CBW531 ; CDS983187F , Lot Number 20EBI798 ; CDS983187F , Lot Number 20FBI369 ; CDS983187F , Lot Number 20HBC286 ; CDS983187F , Lot Number 20JBO733 ; CDS983187F , Lot Number 20LBO434 ; CDS983187F , Lot Number 20XBI626 ; CDS983187F , Lot Number 21CBV530 ; CDS983187F , Lot Number 21FBD645 ; CDS983187F , Lot Number 21FBE341 ; CDS983190L , Lot Number 21HBG895 ; CDS983190L , Lot Number 21IBL907 ; CDS983190L , Lot Number 21JBP547 ; CDS983190L , Lot Number 22ABF852 ; CDS983190L , Lot Number 22ABI219 ; CDS983190L , Lot Number 22ABZ198 ; CDS983190L , Lot Number 22OBM702 ; CDS983190L , Lot Number 22EBE865 ; CDS983190L , Lot Number 22EBO246 ; CDS983190L , Lot Number 20CBY260 ; CDS983190L , Lot Number 20GBG574 ; CDS983190L , Lot Number 20IBD185 ; CDS983190L , Lot Number 20JBF190 ; CDS983190L , Lot Number 20JBK089 ; CDS983190L , Lot Number 20KBH298 ; CDS983190L , Lot Number 21BBM487 ; CDS983190L , Lot Number 21DBA512 ; CDS983190L , Lot Number 21DBS599 ; CDS983190L , Lot Number 21FBH234 ; CDS983216I , Lot Number 21FMC084 ; CDS983216I , Lot Number 21KME577 ; CDS983216I , Lot Number 21LMA223 ; CDS983216I , Lot Number 19DKB865 ; CDS983216I , Lot Number 19FKB746 ; CDS983216I , Lot Number 19FKC261 ; CDS983216I , Lot Number 19GKC764 ; CDS983216I , Lot Number 19HKC570 ; CDS983216I , Lot Number 19KKA061 ; CDS983216I , Lot Number 20CKA293 ; CDS983216I , Lot Number 20FKB303 ; CDS983216I , Lot Number 20IKA578 ; CDS983216I , Lot Number 20JKA229 ; CDS983216I , Lot Number 20JKB178 ; CDS983258O , Lot Number 19BKD021 ; CDS983258O , Lot Number 19CKB235 ; CDS983258O , Lot Number 19DKA634 ; CDS983258O , Lot Number 19EKB872 ; CDS983258Q , Lot Number 19LKA040 ; CDS983258Q , Lot Number 20AKC225 ; CDS983258Q , Lot Number 20EKA166 ; CDS983258Q , Lot Number 20HKB828 ; CDS983258Q , Lot Number 20LKB145 ; CDS983268K , Lot Number 22EBU315 ; CDS983268K , Lot Number 22FBA922 ; CDS983268K , Lot Number 22HBT919 ; CDS983268K , Lot Number 22JBR892 ; CDS983375K , Lot Number 21FBT747 ; CDS983375K , Lot Number 21HBO571 ; CDS983375K , Lot Number 21KBB372 ; CDS983375K , Lot Number 21LBT967 ; CDS983375K , Lot Number 22ABH931 ; CDS983375K , Lot Number 22BBE846 ; CDS983375K , Lot Number 22OBL286 ; CDS983375K , Lot Number 22EBQ746 ; CDS983375K , Lot Number 21DBC044 ; CDS983375K , Lot Number 21DBD644 ; CDS983375K , Lot Number 21EBO479 ; CDS983399D , Lot Number 19BDA410 ; CDS983399D , Lot Number 19DDA367 ; CDS983399D , Lot Number 19DDD080 ; CDS983399D , Lot Number 19EDB946 ; CDS983399D , Lot Number 19FDA746 ; CDS983399D , Lot Number 19GDB539 ; CDS983399D , Lot Number 19IDB070 ; CDS983399D , Lot Number 19JDB137 ; CDS983399D , Lot Number 19KDA249 ; CDS983399D , Lot Number 19LDB389 ; CDS983399D , Lot Number 20ADC092 ; CDS983399D , Lot Number 20BDB503 ; CDS983399D , Lot Number 20CDA897 ; CDS983399D , Lot Number 20DDB453 ; CDS983399D , Lot Number 20EDA505 ; CDS983399D , Lot Number 20FDC137 ; CDS983399D , Lot Number 20GDA649 ; CDS983399D , Lot Number 20HDB922 ; CDS983528L , Lot Number 22LBF933 ; CDS983528L , Lot Number 23DBO030 ; CDS983528L , Lot Number 23FBF795 ; CDS983528M , Lot Number 23GBV846 ; CDS983528M , Lot Number 23HBY043 ; CDS983528M , Lot Number 23JBB312 ; CDS983528M , Lot Number 23KBC890 ; CDS983528M , Lot Number 23LBS318 ; CDS983528M , Lot Number 24BBA972 ; CDS983612C , Lot Number 21FBT729 ; CDS983612C , Lot Number 21HBA496 ; CDS983612C , Lot Number 21HBJ142 ; CDS983612C , Lot Number 21KBA473 ; CDS983612C , Lot Number 19ABI139 ; CDS983612C , Lot Number 22NBB977 ; CDS983612C , Lot Number 19BBF926 ; CDS983612C , Lot Number 22CBP113 ; CDS983612C , Lot Number 19DBK024 ; CDS983612C , Lot Number 22EBV185 ; CDS983612C , Lot Number 22FBA914 ; CDS983612C , Lot Number 19QBA261 ; CDS983612C , Lot Number 19FBZ676 ; CDS983612C , Lot Number 22HBW256 ; CDS983612C , Lot Number 19SBE781 ; CDS983612C , Lot Number 19TBC634 ; CDS983612C , Lot Number 22JBX839 ; CDS983612C , Lot Number 22JBX843 ; CDS983612C , Lot Number 22KBE707 ; CDS983612C , Lot Number 19IBZ377 ; CDS983612C , Lot Number 19JBV285 ; CDS983612C , Lot Number 23BBI398 ; CDS983612C , Lot Number 23CBE852 ; CDS983612C , Lot Number 19LBC813 ; CDS983612C , Lot Number 20BBF090 ; CDS983612C , Lot Number 20BBU696 ; CDS983612C , Lot Number 20CBA302 ; CDS983612C , Lot Number 20CBF672 ; CDS983612C , Lot Number 20EBC772 ; CDS983612C , Lot Number 20EBO999 ; CDS983612C , Lot Number 20IBL769 ; CDS983612C , Lot Number 20JBB847 ; CDS983612C , Lot Number 20JBX573 ; CDS983612C , Lot Number 20LBP811 ; CDS983612C , Lot Number 20LBP957 ; CDS983612C , Lot Number 21ABR713 ; CDS983612C , Lot Number 21BBI035 ; CDS983612C , Lot Number 21BBM011 ; CDS983612C , Lot Number 21EBI491 ; CDS983612C , Lot Number 22CLA958 ; CDS983667F , Lot Number 19BDC005 ; CDS983667F , Lot Number 19BDD457 ; CDS983687F , Lot Number 19ADA436 ; CDS983687F , Lot Number 19BDA010 ; CDS983687F , Lot Number 19BDC641 ; CDS983687F , Lot Number 19CDC989 ; CDS983687F , Lot Number 19DDD381 ; CDS983687F , Lot Number 19EDD251 ; CDS983687F , Lot Number 19GDC474 ; CDS983687F , Lot Number 19IDB830 ; CDS983687F , Lot Number 19KDC053 ; CDS983687F , Lot Number 19LDB716 ; CDS983687F , Lot Number 20CDA139 ; CDS983687F , Lot Number 20FDA467 ; CDS983687F , Lot Number 20GDA705 ; CDS983687F , Lot Number 20IDA181 ; CDS983854B , Lot Number 19BDB424 ; CDS983854B , Lot Number 19EDB479 ; CDS983854B , Lot Number 19GDC856 ; CDS983854B , Lot Number 19IDC873 ; CDS983854B , Lot Number 20ADA078 ; 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Recalling Firm/
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactKarin Johnson
886-359-1704
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by firm
ActionMedline 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.
DistributionWorldwide distribution.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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