Class 2 Device Recall Medline

• Date Initiated by Firm: April 08, 2024
• Date Posted: September 06, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3044-2024
• Recall Event ID: 94583
• Product Classification: Labor and Delivery Kit - Product Code MLS
• Product: Medline Convenience kits labeled as: 1) PACK VAGINAL DELIVERY , Pack Number AM185B ; 2) LABOR & DELIVERY CDS, Pack Number CDS830039AF; 3) LABOR & DELIVERY CDS, Pack Number CDS830039AI; 4) LABOR & DELIVERY CDS, Pack Number CDS830039AJ; 5) LABOR & DELIVERY CDS, Pack Number CDS830039AK; 6) VAGINAL DELIVERY CDS, Pack Number CDS830053G ; 7) VAGINAL DELIVERY CDS, Pack Number CDS830053I ; 8) LABOR & DELIVERY, Pack Number CDS830054P ; 9) VAGINAL DELIVERY PACK-LF, Pack Number CDS830116T ; 10) VAG DELIVERY, ROSCOE, Pack Number CDS830118Q ; 11) VAG DELIVERY, ROSCOE, Pack Number CDS830118R ; 12) VAG DELIVERY, ROSCOE, Pack Number CDS830118S ; 13) VAG DELIVERY, ROSCOE, Pack Number CDS830118T ; 14) VAGINAL DEL/RECOV CDS , Pack Number CDS830131J ; 15) VAGINAL DEL/RECOV CDS , Pack Number CDS830131K ; 16) VAGINAL DEL/RECOV CDS , Pack Number CDS830131L ; 17) MAJOR VAGINAL PROCEDURE , Pack Number CDS830136S ; 18) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137O ; 19) VAGINAL DELIVERY PROCEDURE, Pack Number CDS830137P ; 20) VAGINAL DELIVERY CDS, Pack Number CDS830140A ; 21) VAGINAL DELIVERY CDS, Pack Number CDS830140B ; 22) VAGINAL DELIVERY CDS, Pack Number CDS830178K ; 23) VAGINAL DELIVERY CDS, Pack Number CDS830178L ; 24) VAGINAL DELIVERY CDS, Pack Number CDS830178M ; 25) VAGINAL HYSTERECTOMY CDS, Pack Number CDS830186O ; 26) DELIVERY CDS, Pack Number CDS830199K ; 27) DELIVERY CDS, Pack Number CDS981282O ; 28) OB PROCEDURE-LF , Pack Number CDS981335B ; 29) VAG HYSTERECTOMY CDS, Pack Number CDS981517G ; 30) VAGINAL DELIVERY CDS, Pack Number CDS981776I ; 31) VAGINAL DELIVERY CDS, Pack Number CDS981776J ; 32) VAGINAL DELIVERY CDS, Pack Number CDS981776K ; 33) VAGINAL HYSTERECTOMY CDS, Pack Number CDS982369F ; 34) VAGINAL MAJOR , Pack Number CDS982689O ; 35) VAGINAL MAJOR , Pack Number CDS982689P ; 36) VAGINAL MAJOR , Pack Number CDS982689Q ; 37) VAGINAL MAJOR , Pack Number CDS982689R ; 38) DELIVERY PROCEDURE, Pack Number CDS982761F ; 39) DELIVERY PROCEDURE, Pack Number CDS982761G ; 40) DELIVERY PROCEDURE, Pack Number CDS982761I ; 41) DELIVERY PROCEDURE, Pack Number CDS982761J ; 42) VAGINAL DELIVERY CDS, Pack Number CDS982762D ; 43) VAGINAL DELIVERY CDS, Pack Number CDS982762F ; 44) VAGINAL DELIVERY CDS, Pack Number CDS982762G ; 45) VAGINAL DELIVERY CDS, Pack Number CDS982762I ; 46) VAGINAL DELIVERY CDS, Pack Number CDS982770B ; 47) MAG MAJOR VAGINAL CDS , Pack Number CDS982907K ; 48) MAG MAJOR VAGINAL CDS , Pack Number CDS982907L ; 49) MAG MINOR VAGINAL CDS , Pack Number CDS982908I ; 50) MAG MINOR VAGINAL CDS , Pack Number CDS982908J ; 51) OB-VAGINAL DELIVERY/EMERGENCY , Pack Number CDS982959; 52) VAGINAL DELIVERY CDS, Pack Number CDS983090C ; 53) VAGINAL HYSTERECTOMY CDS, Pack Number CDS983107G ; 54) LABOR & DELIVERY CDS, Pack Number CDS983116C ; 55) LABOR & DELIVERY CDS, Pack Number CDS983116D ; 56) LABOR & DELIVERY CDS, Pack Number CDS983116F ; 57) LABOR & DELIVERY CDS, Pack Number CDS983116G ; 58) LABOR & DELIVERY CDS, Pack Number CDS983116I ; 59) MINOR VAGINAL CDS , Pack Number CDS983119B ; 60) VAGINAL MINOR , Pack Number CDS983268J ; 61) VAGINAL MINOR , Pack Number CDS983268L ; 62) GYN VAGINAL CDS , Pack Number CDS983528J ; 63) ACH MAJOR VAGINAL , Pack Number CDS983641F ; 64) ACH MAJOR VAGINAL , Pack Number CDS983641G ; 65) VAG HYST CDS, Pack Number CDS983697F ; 66) VAGINAL DELIVERY CDS, Pack Number CDS983919C ; 67) VAGINAL DELIVERY CDS, Pack Number CDS983919D ; 68) VAGINAL DELIVERY CDS, Pack Number CDS983919F ; 69) VAGINAL DELIVERY CDS, Pack Number CDS983919G ; 70) OB/GYN CDS, Pack Number CDS984173G ; 71) OB GYN, Pack Number CDS984173I ; 72) GROTH VAGINAL CDS , Pack Number CDS984201P ; 73) GROTH VAGINAL CDS , Pack Number CDS984201Q ; 74) GROTH VAGINAL CDS , Pack Number CDS984201R ; 75) GROTH VAGINAL CDS , Pack Number CDS984201U ; 76) NHP VAGINAL MINOR CDS , Pack Number CDS984235F ; 77) VAGINAL DELIVERY CDS, Pack Number CDS984352C ; 78) VAGINAL DELIVERY CDS, Pack
• Code Information: AM185B , Lot Number 23BBS790 ; AM185B , Lot Number 23IBT868 ; AM185B , Lot Number 23JBW874 ; AM185B , Lot Number 24ABQ730 ; CDS830039AF, Lot Number 19GBO514 ; CDS830039AF, Lot Number 19HBS937 ; CDS830039AF, Lot Number 19JBM007 ; CDS830039AF, Lot Number 19VBF341 ; CDS830039AF, Lot Number 20ABQ286 ; CDS830039AF, Lot Number 20BBR820 ; CDS830039AF, Lot Number 20CBC115 ; CDS830039AF, Lot Number 20EBC561 ; CDS830039AF, Lot Number 20FBH160 ; CDS830039AF, Lot Number 20GBG417 ; CDS830039AF, Lot Number 20GBT038 ; CDS830039AF, Lot Number 20JBA496 ; CDS830039AF, Lot Number 20LBV774 ; CDS830039AF, Lot Number 21ABJ105 ; CDS830039AI, Lot Number 21HBA287 ; CDS830039AI, Lot Number 21HBG893 ; CDS830039AI, Lot Number 21IBJ983 ; CDS830039AI, Lot Number 21LBQ697 ; CDS830039AI, Lot Number 22ABA249 ; CDS830039AI, Lot Number 22CBY819 ; CDS830039AI, Lot Number 22OBB223 ; CDS830039AI, Lot Number 21CBQ656 ; CDS830039AI, Lot Number 21DBP447 ; CDS830039AI, Lot Number 21FBH085 ; CDS830039AJ, Lot Number 22DBI098 ; CDS830039AJ, Lot Number 22EBN206 ; CDS830039AJ, Lot Number 22FBC480 ; CDS830039AJ, Lot Number 22FBD486 ; CDS830039AJ, Lot Number 22FBT263 ; CDS830039AJ, Lot Number 22FBW862 ; CDS830039AK, Lot Number 22JBF161 ; CDS830039AK, Lot Number 22KBQ120 ; CDS830039AK, Lot Number 22LBC150 ; CDS830039AK, Lot Number 23ABF855 ; CDS830039AK, Lot Number 23CBH440 ; CDS830039AK, Lot Number 23FBK921 ; CDS830039AK, Lot Number 23FBK922 ; CDS830039AK, Lot Number 23GBA194 ; CDS830039AK, Lot Number 23HBO379 ; CDS830039AK, Lot Number 23IBE023 ; CDS830039AK, Lot Number 23JBL894 ; CDS830039AK, Lot Number 23KBB125 ; CDS830053G , Lot Number 21HBR110 ; CDS830053G , Lot Number 21IBJ984 ; CDS830053G , Lot Number 21KBT291 ; CDS830053G , Lot Number 21KBW772 ; CDS830053G , Lot Number 22BBK560 ; CDS830053G , Lot Number 19ABC405 ; CDS830053G , Lot Number 22BBQ057 ; CDS830053G , Lot Number 19ABX756 ; CDS830053G , Lot Number 22OBE801 ; CDS830053G , Lot Number 19CBI663 ; CDS830053G , Lot Number 22DBN943 ; CDS830053G , Lot Number 19EBC550 ; CDS830053G , Lot Number 22GBA870 ; CDS830053G , Lot Number 19FBN913 ; CDS830053G , Lot Number 19HBZ072 ; CDS830053G , Lot Number 19IBI894 ; CDS830053G , Lot Number 19IBP482 ; CDS830053G , Lot Number 19JBP810 ; CDS830053G , Lot Number 19LBL676 ; CDS830053G , Lot Number 20ABL825 ; CDS830053G , Lot Number 20CBV686 ; CDS830053G , Lot Number 20FBN246 ; CDS830053G , Lot Number 20GBP178 ; CDS830053G , Lot Number 20IBC356 ; CDS830053G , Lot Number 20IBG769 ; CDS830053G , Lot Number 20LBV829 ; CDS830053G , Lot Number 21ABM101 ; CDS830053G , Lot Number 21BBA375 ; CDS830053G , Lot Number 21CBA201 ; CDS830053G , Lot Number 21CBB711 ; CDS830053I , Lot Number 22GBB014 ; CDS830053I , Lot Number 22IBJ347 ; CDS830053I , Lot Number 22JBP418 ; CDS830053I , Lot Number 22KBF644 ; CDS830053I , Lot Number 22KBS025 ; CDS830053I , Lot Number 23BBA669 ; CDS830053I , Lot Number 23BBJ070 ; CDS830053I , Lot Number 23BBN831 ; CDS830053I , Lot Number 23EBD612 ; CDS830053I , Lot Number 23FBA344 ; CDS830053I , Lot Number 23GBD900 ; CDS830053I , Lot Number 23IBJ528 ; CDS830053I , Lot Number 23IBS206 ; CDS830053I , Lot Number 23JBO100 ; CDS830053I , Lot Number 23KBR822 ; CDS830053I , Lot Number 24ABB121 ; CDS830053I , Lot Number 24BBN779 ; CDS830054P , Lot Number 21JBO031 ; CDS830054P , Lot Number 21JBX762 ; CDS830116T , Lot Number 21EMB670 ; CDS830116T , Lot Number 21GMA024 ; CDS830116T , Lot Number 21JMB604 ; CDS830116T , Lot Number 21JMF853 ; CDS830116T , Lot Number 21JMH576 ; CDS830116T , Lot Number 21LMF690 ; CDS830116T , Lot Number 22DMB054 ; CDS830116T , Lot Number 22DMI608 ; CDS830116T , Lot Number 22GMA496 ; CDS830116T , Lot Number 22HMG373 ; CDS830116T , Lot Number 22IME198 ; CDS830116T , Lot Number 22JMD253 ; CDS830116T , Lot Number 22KMF160 ; CDS830116T , Lot Number 22KMG955 ; CDS830116T , Lot Number 22LMD441 ; CDS830116T , Lot Number 23BME252 ; CDS830116T , Lot Number 23CME301 ; CDS830116T , Lot Number 23EMD013 ; CDS830116T , Lot Number 23GMD216 ; CDS830116T , Lot Number 23IMB391 ; CDS830116T , Lot Number 23JMA001 ; CDS830116T , Lot Number 23JMB328 ; CDS830116T , Lot Number 23KMC556 ; CDS830116T , Lot Number 24AMG394 ; CDS830116T , Lot Number 24BMA659 ; CDS830116T , Lot Number 19AKA494 ; CDS830116T , Lot Number 19BKC413 ; CDS830116T , Lot Number 19CKD534 ; CDS830116T , Lot Number 19FKA446 ; CDS830116T , Lot Number 19GKB740 ; CDS830116T , Lot Number 19HKC516 ; CDS830116T , Lot Number 19IKB563 ; CDS830116T , Lot Number 19JKB867 ; CDS830116T , Lot Number 19LKB874 ; CDS830116T , Lot Number 20BKB549 ; CDS830116T , Lot Number 20EKA256 ; CDS830116T , Lot Number 20EKB831 ; CDS830116T , Lot Number 20FKB612 ; CDS830116T , Lot Number 20HKB062 ; CDS830116T , Lot Number 20IKB086 ; CDS830116T , Lot Number 20LKB352 ; CDS830116T , Lot Number 21BKA056 ; CDS830116T , Lot Number 21CKA723 ; CDS830118Q , Lot Number 19AKC562 ; CDS830118Q , Lot Number 19BKB849 ; CDS830118Q , Lot Number 19CKC028 ; CDS830118Q , Lot Number 19DKC654 ; CDS830118Q , Lot Number 19FKA351 ; CDS830118R , Lot Number 19IKA570 ; CDS830118R , Lot Number 19KKC104 ; CDS830118R , Lot Number 20BKA872 ; CDS830118S , Lot Number 21FMD347 ; CDS830118S , Lot Number 21FMF056 ; CDS830118S , Lot Number 21GMF219 ; CDS830118S , Lot Number 21JME711 ; CDS830118S , Lot Number 22BMA878 ; CDS830118S , Lot Number 22CME725 ; CDS830118S , Lot Number 22CMG970 ; CDS830118S , Lot Number 22DMD957 ; CDS830118S , Lot Number 22EME901 ; CDS830118S , Lot Number 22HME575 ; CDS830118S , Lot Number 22IMH126 ; CDS830118S , Lot Number 22JMB663 ; CDS830118S , Lot Number 22JMF150 ; CDS830118S , Lot Number 20EKB812 ; CDS830118S , Lot Number 20HKB275 ; CDS830118S , Lot Number 20LKA346 ; CDS830118S , Lot Number 20LKB137 ; CDS830118S , Lot Number 21AKB216 ; CDS830118S , Lot Number 21CKA306 ; CDS830118S , Lot Number 21CKB178 ; CDS830118S , Lot Number 21DKA367 ; CDS830118T , Lot Number 22LMC177 ; CDS830118T , Lot Number 23AMB057 ; CDS830118T , Lot Number 23FMI895 ; CDS830118T , Lot Number 23GMF443 ; CDS830118T , Lot Number 23HMF250 ; CDS830118T , Lot Number 23KMG894 ; CDS830118T , Lot Number 23KMJ692 ; CDS830118T , Lot Number 23LME667 ; CDS830131J , Lot Number 19ABM872 ; CDS830131J , Lot Number 19CBD005 ; CDS830131J , Lot Number 19DBM651 ; CDS830131J , Lot Number 19EBH293 ; CDS830131J , Lot Number 19FBJ430 ; CDS830131J , Lot Number 19RBC374 ; CDS830131J , Lot Number 19HBV872 ; CDS830131J , Lot Number 19JBJ533 ; CDS830131J , Lot Number 19VBB798 ; CDS830131J , Lot Number 19KBA662 ; CDS830131K , Lot Number 21FBS279 ; CDS830131K , Lot Number 21HBF889 ; CDS830131K , Lot Number 21IBU364 ; CDS830131K , Lot Number 21IBX809 ; CDS830131K , Lot Number 21LBT876 ; CDS830131K , Lot Number 22OBM263 ; CDS830131K , Lot Number 22FBB172 ; CDS830131K , Lot Number 20ABP025 ; CDS830131K , Lot Number 20ABU699 ; CDS830131K , Lot Number 20EBS035 ; CDS830131K , Lot Number 20GBB065 ; CDS830131K , Lot Number 20GBC231 ; CDS830131K , Lot Number 20HBO225 ; CDS830131K , Lot Number 21ABC255 ; CDS830131K , Lot Number 21ABW317 ; CDS830131K , Lot Number 21BBB750 ; CDS830131K , Lot Number 21BBK116 ; CDS830131L , Lot Number 22GBD116 ; CDS830131L , Lot Number 22IBR912 ; CDS830131L , Lot Number 22LBM244 ; CDS830131L , Lot Number 22LBM698 ; CDS830131L , Lot Number 23ABF942 ; CDS830131L , Lot Number 23ABQ796 ; CDS830131L , Lot Number 23DBE272 ; CDS830131L , Lot Number 23DBM934 ; CDS830131L , Lot Number 23EBN834 ; CDS830131L , Lot Number 23FBF343 ; CDS830131L , Lot Number 23IBJ058 ; CDS830131L , Lot Number 23JBL895 ; CDS830131L , Lot Number 23LBM365 ; CDS830136S , Lot Number 20GBL464 ; CDS830136S , Lot Number 20HBM600 ; CDS830137O , Lot Number 21HBF463 ; CDS830137O , Lot Number 21HBF464 ; CDS830137O , Lot Number 21LBC576 ; CDS830137O , Lot Number 21LBO564 ; CDS830137O , Lot Number 19ABN116 ; CDS830137O , Lot Number 19CBA050 ; CDS830137O , Lot Number 22DBO876 ; CDS830137O , Lot Number 22DBP352 ; CDS830137O , Lot Number 19EBY135 ; CDS830137O , Lot Number 19FBG825 ; CDS830137O , Lot Number 22GBS220 ; CDS830137O , Lot Number 19FBZ899 ; CDS830137O , Lot Number 22HBN167 ; CDS830137O , Lot Number 19IBB129 ; CDS830137O , Lot Number 22KBH567 ; CDS830137O , Lot Number 22KBU527 ; CDS830137O , Lot Number 22LBG633 ; CDS830137O , Lot Number 22LBG634 ; CDS830137O , Lot Number 19JBW637 ; CDS830137O , Lot Number 23ABH562 ; CDS830137O , Lot Number 23BBR625 ; CDS830137O , Lot Number 19LBH126 ; CDS830137O , Lot Number 23CBR366 ; CDS830137O , Lot Number 23EBI079 ; CDS830137O , Lot Number 23GBH723 ; CDS830137O , Lot Number 20DBB164 ; CDS830137O , Lot Number 20DBB421 ; CDS830137O , Lot Number 23HBM939 ; CDS830137O , Lot Number 23IBF203 ; CDS830137O , Lot Number 20EBR859 ; CDS830137O , Lot Number 21ABK401 ; CDS830137O , Lot Number 21ABL310 ; CDS830137O , Lot Number 21BBO664 ; CDS830137O , Lot Number 21EBI160 ; CDS830137P , Lot Number 23JBY482 ; CDS830137P , Lot Number 23KBH279 ; CDS830137P , Lot Number 23KBM400 ; CDS830137P , Lot Number 23LBT868 ; CDS830137P , Lot Number 24ABX955 ; CDS830140A , Lot Number 19AKB478 ; CDS830140A , Lot Number 19CKC205 ; CDS830140A , Lot Number 19EKB389 ; CDS830140A , Lot Number 19FKC144 ; CDS830140A , Lot Number 19HKC969 ; CDS830140A , Lot Number 19JKA539 ; CDS830140A , Lot Number 19KKB917 ; CDS830140A , Lot Number 20AKA780 ; CDS830140B , Lot Number 21FMF221 ; CDS830140B , Lot Number 21HMG501 ; CDS830140B , Lot Number 21JMB548 ; CDS830140B , Lot Number 21KMF087 ; CDS830140B , Lot Number 21LME158 ; CDS830140B , Lot Number 21LMG072 ; CDS830140B , Lot Number 22AMF900 ; CDS830140B , Lot Number 22DMH110 ; CDS830140B , Lot Number 22GMB325 ; CDS830140B , Lot Number 22HMA893 ; CDS830140B , Lot Number 22HMB582 ; CDS830140B , Lot Number 23AMC002 ; CDS830140B , Lot Number 23FMA953 ; CDS830140B , Lot Number 23IMC561 ; CDS830140B , Lot Number 23JMD151 ; CDS830140B , Lot Number 23LMG886 ; CDS830140B , Lot Number 20CKA191 ; CDS830140B , Lot Number 20EKB854 ; CDS830140B , Lot Number 20FKA370 ; CDS830140B , Lot Number 20IKA974 ; CDS830140B , Lot Number 20LKA970 ; CDS830140B , Lot Number 21BKA446 ; CDS830140B , Lot Number 21DKA052 ; CDS830178K , Lot Number 19ABJ678 ; CDS830178K , Lot Number 19BBN827 ; CDS830178K , Lot Number 19CBE060 ; CDS830178K , Lot Number 19CBL320 ; CDS830178K , Lot Number 19EBB612 ; CDS830178K , Lot Number 19FBY123 ; CDS830178L , Lot Number 21HBD363 ; CDS830178L , Lot Number 21HBI052 ; CDS830178L , Lot Number 21IBG585 ; CDS830178L , Lot Number 21IBO576 ; CDS830178L , Lot Number 21KBW658 ; CDS830178L , Lot Number 21WBA692 ; CDS830178L , Lot Number 19IBB997 ; CDS830178L , Lot Number 19JBG718 ; CDS830178L , Lot Number 19VBH222 ; CDS830178L , Lot Number 19KBH537 ; CDS830178L , Lot Number 19LBQ608 ; CDS830178L , Lot Number 20ABE276 ; CDS830178L , Lot Number 20CBV581 ; CDS830178L , Lot Number 20EBH246 ; CDS830178L , Lot Number 20FBD482 ; CDS830178L , Lot Number 20FBT670 ; CDS830178L , Lot Number 20HBB911 ; CDS830178L , Lot Number 20IBF872 ; CDS830178L , Lot Number 20WBC587 ; CDS830178L , Lot Number 20LBM260 ; CDS830178L , Lot Number 20LBO258 ; CDS830178L , Lot Number 21DBU721 ; CDS830178L , Lot Number 21EBD430 ; CDS830178M , Lot Number 22OBK922 ; CDS830178M , Lot Number 22DBF335 ; CDS830178M , Lot Number 22FBG123 ; CDS830178M , Lot Number 22FBS812 ; CDS830178M , Lot Number 22GBD999 ; CDS830178M , Lot Number 22GBE764 ; CDS830178M , Lot Number 22HBH307 ; CDS830178M , Lot Number 22HBP448 ; CDS830178M , Lot Number 22HBU972 ; CDS830178M , Lot Number 22KBH071 ; CDS830178M , Lot Number 22KBH073 ; CDS830178M , Lot Number 22KBS114 ; CDS830178M , Lot Number 23ABQ429 ; CDS830178M , Lot Number 23BBR688 ; CDS830178M , Lot Number 23DBE092 ; CDS830178M , Lot Number 23FBN547 ; CDS830178M , Lot Number 23HBC372 ; CDS830178M , Lot Number 23IBD004 ; CDS830178M , Lot Number 23IBP661 ; CDS830178M , Lot Number 23KBO586 ; CDS830178M , Lot Number 23LBL554 ; CDS830186O , Lot Number 21IBL001 ; CDS830186O , Lot Number 21IBP906 ; CDS830186O , Lot Number 19GBO688 ; CDS830186O , Lot Number 19IBB512 ; CDS830186O , Lot Number 20ABF338 ; CDS830186O , Lot Number 20ABW761 ; CDS830186O , Lot Number 20BBW838 ; CDS830186O , Lot Number 20GBL495 ; CDS830186O , Lot Number 20IBH985 ; CDS830186O , Lot Number 21ABA124 ; CDS830186O , Lot Number 21DBJ851 ; CDS830186O , Lot Number 21EBH575 ; CDS830199K , Lot Number 21EBQ758 ; CDS830199K , Lot Number 21HMA072 ; CDS830199K , Lot Number 21IMC051 ; CDS830199K , Lot Number 21JMC634 ; CDS830199K , Lot Number 21JMI113 ; CDS830199K , Lot Number 21LMF692 ; CDS830199K , Lot Number 22CMD476 ; CDS830199K , Lot Number 22CMH405 ; CDS830199K , Lot Number 22FMF784 ; CDS830199K , Lot Number 22GMH330 ; CDS830199K , Lot Number 22JMC493 ; CDS830199K , Lot Number 22JME636 ; CDS830199K , Lot Number 22LMA572 ; CDS830199K , Lot Number 23AMG283 ; CDS830199K , Lot Number 23BMH165 ; CDS830199K , Lot Number 23DMI152 ; CDS830199K , Lot Number 23HMB030 ; CDS830199K , Lot Number 23JMI193 ; CDS830199K , Lot Number 23KMB927 ; CDS830199K , Lot Number 23KME352 ; CDS830199K , Lot Number 23LMG781 ; CDS830199K , Lot Number 24BME168 ; CDS830199K , Lot Number 24BMI779 ; CDS830199K , Lot Number 19AKC008 ; CDS830199K , Lot Number 19BKC412 ; CDS830199K , Lot Number 19DKC056 ; CDS830199K , Lot Number 19FKB067 ; CDS830199K , Lot Number 19HKB662 ; 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• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin 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: Under Investigation by firm
• 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.
• Total Product Life Cycle: TPLC 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.