FDA Enforcement Class II Ongoing

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

Recall: Z-3044-2024 · Reported September 18, 2024

Enforcement

Recall Number: Z-3044-2024
Event ID: 94583
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: MEDLINE INDUSTRIES, LP - Northfield
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Report Date: September 18, 2024
Initiation Date: April 8, 2024
Classification Date: September 6, 2024
Address: 3 Lakes Dr, Northfield, IL, 60093-2753, United States

Description

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.

Code Info

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 ; CDS830199K , Lot Number 19HKC032 ; CDS830199K , Lot Number 19HKC564 ; CDS830199K , Lot Number 19JKA535 ; CDS830199K , Lot Number 19KKA779 ; CDS830199K , Lot Number 19LKA802 ; CDS830199K , Lot Number 20BKA890 ; CDS830199K , Lot Number 20CKB085 ; CDS830199K , Lot Number 20FKC029 ; CDS830199K , Lot Number 20IKA233 ; CDS830199K , Lot Number 20LKA824 ; CDS830199K , Lot Number 21BKA414 ; CDS830199K , Lot Number 21DKA652 ; CDS830199K , Lot Number 21DKA741 ; CDS981282O , Lot Number 21GBT341 ; CDS981282O , Lot Number 21HBT606 ; CDS981282O , Lot Number 21IBJ281 ; CDS981282O , Lot Number 21JBU157 ; CDS981282O , Lot Number 21JBZ408 ; CDS981282O , Lot Number 22OBA576 ; CDS981282O , Lot Number 19DBI202 ; CDS981282O , Lot Number 22EBA368 ; CDS981282O , Lot Number 22EBS511 ; CDS981282O , Lot Number 19EBL448 ; CDS981282O , Lot Number 19EBR663 ; CDS981282O , Lot Number 22FBO708 ; CDS981282O , Lot Number 22IBB748 ; CDS981282O , Lot Number 19HBL765 ; CDS981282O , Lot Number 22JBQ064 ; CDS981282O , Lot Number 19LBH959 ; CDS981282O , Lot Number 20BBM044 ; CDS981282O , Lot Number 20BBQ360 ; CDS981282O , Lot Number 23FBT672 ; CDS981282O , Lot Number 20DBS530 ; CDS981282O , Lot Number 23HBQ790 ; CDS981282O , Lot Number 20EBH247 ; CDS981282O , Lot Number 20GBR707 ; CDS981282O , Lot Number 20HBV938 ; CDS981282O , Lot Number 20JBP313 ; CDS981282O , Lot Number 20LBL376 ; CDS981282O , Lot Number 21ABR730 ; CDS981282O , Lot Number 21BBB800 ; CDS981335B , Lot Number 19ABV228 ; CDS981335B , Lot Number 19BBN593 ; CDS981335B , Lot Number 19BBO323 ; CDS981335B , Lot Number 19DBT117 ; CDS981335B , Lot Number 19HBK357 ; CDS981335B , Lot Number 19IBW706 ; CDS981335B , Lot Number 19LBC870 ; CDS981335B , Lot Number 20BBR861 ; CDS981335B , Lot Number 20CBF519 ; CDS981335B , Lot Number 20CBX716 ; CDS981517G , Lot Number 19CDB668 ; CDS981517G , Lot Number 19EDB868 ; CDS981517G , Lot Number 19IDC145 ; CDS981517G , Lot Number 19JDC685 ; CDS981517G , Lot Number 20ADB791 ; CDS981517G , Lot Number 20EDA532 ; CDS981517G , Lot Number 20IDA004 ; CDS981517G , Lot Number 21ADA848 ; 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PHS400213010C, Lot Number 20CDB975 ; PHS400213010C, Lot Number 20EDB509 ; PHS400213010C, Lot Number 20JDA119 ; PHS400213010C, Lot Number 21ADB905 ; PHS400213010C, Lot Number 21CDB259 ; PHS400213010C, Lot Number 21CDB656 ; PHS400213010C, Lot Number 21FDC392 ; PHS400213010C, Lot Number 21IDB325 ; PHS400213010C, Lot Number 21LDC017 ; PHS400213010C, Lot Number 22CDA935 ; PHS400213010C, Lot Number 22EDB151 ; PHS774463B , Lot Number 21FBO250 ; PHS774463B , Lot Number 21IBJ569 ; PHS774463B , Lot Number 21LBS187 ; PHS774463B , Lot Number 22BBT408 ; PHS774463B , Lot Number 22NBA203 ; PHS774463B , Lot Number 19DBF742 ; PHS774463B , Lot Number 19GBK124 ; PHS774463B , Lot Number 19KBO124 ; PHS774463B , Lot Number 20BBB205 ; PHS774463B , Lot Number 20CBH045 ; PHS774463B , Lot Number 20DBJ713 ; PHS774463B , Lot Number 20EBH205 ; PHS774463B , Lot Number 20IBJ779 ; PHS774463B , Lot Number 21BBN875 ; PHS774463B , Lot Number 21DBN929 ; PHS774463B , Lot Number 23AMA675 ; PHS774463B , Lot Number 23BMA729 ; PHS774463C , Lot Number 23FMF412 ; PHS774463C , Lot Number 23GMI926 ; PHS774463C , Lot Number 23HME028 ; PHS983563000A, Lot Number 23FBP938 ; PHS983563000A, Lot Number 23HBE605 ; PHS983563000A, Lot Number 23JBA657 ; PHS983563000A, Lot Number 23KBC652 ; PHS983563000A, Lot Number 23LBP104 ; PHS983563000A, Lot Number 24ABW455 ; PHS983563000A, Lot Number 21DMD652 ; PHS983563000A, Lot Number 21GMA524 ; PHS983563000A, Lot Number 21IMA476 ; PHS983563000A, Lot Number 21IMH874 ; PHS983563000A, Lot Number 21JMH121 ; PHS983563000A, Lot Number 21LMC384 ; PHS983563000A, Lot Number 22AMD107 ; PHS983563000A, Lot Number 22BMH519 ; PHS983563000A, Lot Number 22DMC550 ; PHS983563000A, Lot Number 22EMG465 ; PHS983563000A, Lot Number 22FMD602 ; PHS983563000A, Lot Number 22HMH320 ; PHS983563000A, Lot Number 22LMD331 ; PHS983563000A, Lot Number 23AMI063 ; PHS983563000A, Lot Number 23CME017 ; PHS983563000A, Lot Number 23FMF241 ; SYNJ10248, Lot Number 19ABR308 ; SYNJ10248, Lot Number 19DBQ103 ; SYNJ10248, Lot Number 19FBE008 ; SYNJ10248, Lot Number 19GBL866 ; SYNJ10248, Lot Number 19GBV040 ; SYNJ10248A , Lot Number 19UBC251 ; SYNJ10248A , Lot Number 19JBG097 ; SYNJ10248A , Lot Number 20CBH468 ; SYNJ10248A , Lot Number 20EBW260 ; SYNJ10248A , Lot Number 20FBK183 ; SYNJ10248B , Lot Number 21HBU684 ; SYNJ10248B , Lot Number 21HBU687 ; SYNJ10248B , Lot Number 21IBM226 ; SYNJ10248B , Lot Number 21JBL976 ; SYNJ10248B , Lot Number 21KBD247 ; SYNJ10248B , Lot Number 21LBA495 ; SYNJ10248B , Lot Number 22BBE012 ; SYNJ10248B , Lot Number 22EBD778 ; SYNJ10248B , Lot Number 22GBB268 ; SYNJ10248B , Lot Number 22IBG268 ; SYNJ10248B , Lot Number 22IBT913 ; SYNJ10248B , Lot Number 23ABG378 ; SYNJ10248B , Lot Number 23BBM822 ; SYNJ10248B , Lot Number 23DBG650 ; SYNJ10248B , Lot Number 23EBD565 ; SYNJ10248B , Lot Number 23FBB600 ; SYNJ10248B , Lot Number 23HBV715 ; SYNJ10248B , Lot Number 23IBR890 ; SYNJ10248B , Lot Number 23KBE181 ; SYNJ10248B , Lot Number 20GBP446 ; SYNJ10248B , Lot Number 20IBB766 ; SYNJ10248B , Lot Number 24ABA624 ; SYNJ10248B , Lot Number 20JBO635

Distribution

Worldwide distribution.