Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number
Summary
The FDA issued a Class II for Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654 by MEDLINE INDUSTRIES, LP - Northfield. Reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issue.
Details
Source
Device Recall
External ID
Z-2764-2024
Action Date
2024-09-04
Status
Ongoing
Category
device
Product Description
Medline procedural kits labeled as: 1) ALL DOC EYE PACK, Pack Number DYNJ51654A ; 2) ASC CATARACT PACK , Pack Number DYNJ0855117O ; 3) BAI , Pack Number DYNJ53847D ; 4) BASIC EYE PACK, Pack Number DYNJ83699A ; 5) BASIC EYE PACK, Pack Number DYNJ81805; 6) BASIC EYE PACK, Pack Number DYNJ83699A ; 7) BYERS CATARACT, Pack Number DYNJ67344; 8) BYERS CATARACT, Pack Number DYNJ67344H ; 9) CATARACT, Pack Number DYNJ44544B ; 10) CATARACT, Pack Number DYNJ54713C ; 11) CATARACT CDS , Pack Number CDS983804F ; 12) CATARACT CDS, Pack Number CDS983804F ; 13) CATARACT DR MALONE PACK , Pack Number DYNJ51590A ; 14) CATARACT DR MULROONEY PACK, Pack Number DYNJ51595A ; 15) CATARACT DR STEVENS PACK, Pack Number DYNJ51593C ; 16) CATARACT L J, Pack Number DYNJ40056A ; 17) CATARACT PACK, Pack Number CMPJ03235C ; 18) CATARACT PACK, Pack Number DYNJ80316A ; 19) CATARACT PACK, Pack Number VAL011CTASF; 20) CATARACT PACK , Pack Number CMPJ03235C ; 21) CATARACT PACK , Pack Number DYNJ31020K ; 22) CATARACT PACK , Pack Number DYNJ31020L ; 23) CATARACT PACK , Pack Number DYNJ54790D ; 24) CATARACT PACK , Pack Number DYNJ64962; 25) CATARACT PACK , Pack Number DYNJ80316; 26) CATARACT PACK , Pack Number DYNJ80316A ; 27) CATARACT PACK , Pack Number DYNJ80487A ; 28) CATARACT PACK , Pack Number DYNJ80487B ; 29) CATARACT PACK , Pack Number DYNJ80487C ; 30) CATARACT PACK , Pack Number DYNJ80487F ; 31) CATARACT PACK , Pack Number DYNJ84265A ; 32) CATARACT PACK , Pack Number DYNJ85332; 33) CATARACT PACK , Pack Number LYN042CPFEG; 34) CATARACT PACK , Pack Number VAL011CTASF; 35) CATARACT PACK , Pack Number DYNJ43048K ; 36) CATARACT PACK , Pack Number DYNJ52649D ; 37) CATARACT PACK , Pack Number DYNJ52649F ; 38) CATARACT PACK , Pack Number DYNJ55682D ; 39) CATARACT PACK , Pack Number DYNJ63284A ; 40) CATARACT PACK , Pack Number DYNJ63284B ; 41) CATARACT PACK , Pack Number DYNJ66410B ; 42) CATARACT PACK , Pack Number DYNJ85042; 43) CATARACT PACK , Pack Number DYNJ68836B ; 44) CATARACT PACK - GB, Pack Number DYNJ54790F ; 45) CATARACT PACK LUTHER HOSPITAL , Pack Number DYNJ61699D ; 46) CATARACT PACK WITH NO TUB , Pack Number DYNJ80232; 47) CATARACT PACK WITH NO TUB , Pack Number DYNJ80232H ; 48) CATARACT PACK-LF, Pack Number DYNJ42830D ; 49) CATARACT PACK-LF, Pack Number DYNJ0200004B ; 50) CATARACT PACK-LF, Pack Number DYNJ36100C ; 51) CATARACT TRAY , Pack Number DYNJ44356I ; 52) CATARACT TRAY , Pack Number DYNJ44356J ; 53) CATARACT TRAY , Pack Number DYNJ62410A ; 54) COVENANT RETINAL TRAY , Pack Number EYT102K; 55) CUSTOM EYE TRAY #1, Pack Number DYNJ66003D ; 56) CUSTOM EYE TRAY #1, Pack Number DYNJ66003C ; 57) CUSTOM EYE TRAY #1, Pack Number DYNJ66003D ; 58) CUSTOM EYE TRAY #2 , Pack Number DYNJ66004B ; 59) CUSTOM EYE TRAY #2, Pack Number DYNJ66004A ; 60) CUSTOM EYE TRAY #2, Pack Number DYNJ66004B ; 61) DDD VITRECTOMY PACK-LF, Pack Number DYNJ19973S ; 62) DR FLOOD EYE PACK , Pack Number DYNJ57258G ; 63) DR. OSTER GROSSER EYE PACK, Pack Number DYNJ44671C ; 64) DR. OSTER GROSSER EYE PACK, Pack Number DYNJ44671D ; 65) EYE , Pack Number DYNJ0559863K ; 66) EYE BCS PACK, Pack Number DYNJ37682J ; 67) EYE BCS PACK, Pack Number DYNJ37682K ; 68) EYE CATARACT (BASIC EYE), Pack Number DYNJ63272B ; 69) EYE INJECTION KIT , Pack Number MNS13080 ; 70) EYE MUSCLE PACK , Pack Number DYNJ66022A ; 71) EYE MUSCLE TRAY FFX , Pack Number DYNJ63638A ; 72) EYE PACK, Pack Number DYNJ40135C ; 73) EYE PACK, Pack Number DYNJ55484A ; 74) EYE PACK, Pack Number DYNJ60960A ; 75) EYE PACK, Pack Number DYNJ67973B ; 76) EYE PACK, Pack Number DYNJ83799C ; 77) EYE PACK, Pack Number VAL013EPWEC; 78) EYE PACK, Pack Number VAL038BSCLC; 79) EYE PACK, Pack Number DYNJ56293D ; 80) EYE PACK, Pack Number DYNJ64051C ; 81) EYE PACK, Pack Number CMPJ06528F ; 82) EYE PACK, Pack Number DYNJ38400I ; 83) EYE PACK, Pack Number DYNJ38400J ; 84) EYE PACK, Pack Number DYNJ64284C ; 85) EYE PACK, Pack Number DYNJ64284D ; 86) EYE PACK, Pack Numbe
Lot/Code Info: DYNJ51654A , Lot Number:23HBZ446 ; DYNJ0855117O , Lot Number:23GME420 ; DYNJ0855117O , Lot Number:23IMA529 ; DYNJ0855117O , Lot Number:24AMG373 ; DYNJ53847D , Lot Number:23AMJ016 ; DYNJ53847D , Lot Number:23EMJ451 ; DYNJ53847D , Lot Number:23FMF604 ; DYNJ53847D , Lot Number:23JMI394 ; DYNJ53847D , Lot Number:23KMB963 ; DYNJ53847D , Lot Number:24AMA722 ; DYNJ83699A , Lot Number:24CMG922 ; DYNJ81805, Lot Number:23FMD167 ; DYNJ81805, Lot Number:23GMA680 ; DYNJ81805, Lot Number:23JMD040 ; DYNJ81805, Lot Number:24AMA541 ; DYNJ83699A , Lot Number:23KMA807 ; DYNJ83699A , Lot Number:24AMB925 ; DYNJ67344, Lot Number:23IMH376 ; DYNJ67344, Lot Number:23JMG829 ; DYNJ67344H , Lot Number:23IMH376 ; DYNJ67344H , Lot Number:23JMG829 ; DYNJ44544B , Lot Number:24BBN345 ; DYNJ54713C , Lot Number:23GBR621 ; CDS983804F , Lot Number:24CBG535 ; CDS983804F , Lot Number:23BBN605 ; CDS983804F , Lot Number:23BBU281 ; CDS983804F , Lot Number:23EBC831 ; CDS983804F , Lot Number:23EBW202 ; CDS983804F , Lot Number:23FBH069 ; CDS983804F , Lot Number:23HBD970 ; CDS983804F , Lot Number:23IBC407 ; CDS983804F , Lot Number:23JBF548 ; DYNJ51590A , Lot Number:21KBS483 ; DYNJ51590A , Lot Number:21KBS490 ; DYNJ51590A , Lot Number:22GBD368 ; DYNJ51590A , Lot Number:22JBL806 ; DYNJ51590A , Lot Number:22JBU147 ; DYNJ51590A , Lot Number:22JBW972 ; DYNJ51590A , Lot Number:23FBR199 ; DYNJ51590A , Lot Number:23IBJ742 ; DYNJ51590A , Lot Number:23JBK026 ; DYNJ51595A , Lot Number:21IBN715 ; DYNJ51595A , Lot Number:21KBJ227 ; DYNJ51595A , Lot Number:21LBQ210 ; DYNJ51595A , Lot Number:22FBB062 ; DYNJ51595A , Lot Number:22GBN540 ; DYNJ51595A , Lot Number:22IBU646 ; DYNJ51595A , Lot Number:23ABO675 ; DYNJ51595A , Lot Number:23CBL791 ; DYNJ51595A , Lot Number:23EBA140 ; DYNJ51595A , Lot Number:23IBM004 ; DYNJ51593C , Lot Number:21KBI577 ; DYNJ51593C , Lot Number:21KBT571 ; DYNJ51593C , Lot Number:21LBT302 ; DYNJ51593C , Lot Number:22JBA148 ; DYNJ51593C , Lot Number:23BBK907 ; DYNJ40056A , Lot Number:23HMG522 ; DYNJ40056A , Lot Number:23KMB058 ; CMPJ03235C , Lot Number:24CBJ839 ; DYNJ80316A , Lot Number:24CBF142 ; VAL011CTASF, Lot Number:24CBL957 ; CMPJ03235C , Lot Number:23BBB565 ; CMPJ03235C , Lot Number:23GBO681 ; CMPJ03235C , Lot Number:24BBI378 ; DYNJ31020K , Lot Number:21LBL497 ; DYNJ31020K , Lot Number:22OBC488 ; DYNJ31020K , Lot Number:22FBT609 ; DYNJ31020K , Lot Number:22HBA842 ; DYNJ31020K , Lot Number:23BBB378 ; DYNJ31020K , Lot Number:23CBJ094 ; DYNJ31020K , Lot Number:23DBQ602 ; DYNJ31020K , Lot Number:23FBK551 ; DYNJ31020K , Lot Number:23JBT069 ; DYNJ31020K , Lot Number:20XBG244 ; DYNJ31020K , Lot Number:21EBB373 ; DYNJ31020L , Lot Number:23LBO289 ; DYNJ31020L , Lot Number:23LBS944 ; DYNJ54790D , Lot Number:21KBK564 ; DYNJ54790D , Lot Number:21LBP312 ; DYNJ64962, Lot Number:22EBE357 ; DYNJ64962, Lot Number:22GBM208 ; DYNJ64962, Lot Number:23CBM665 ; DYNJ64962, Lot Number:23DBC274 ; DYNJ64962, Lot Number:23EBD021 ; DYNJ64962, Lot Number:23FBV254 ; DYNJ64962, Lot Number:21ABD721 ; DYNJ64962, Lot Number:21ABG947 ; DYNJ80316, Lot Number:22GBK573 ; DYNJ80316A , Lot Number:23EBX492 ; DYNJ80316A , Lot Number:23KBB868 ; DYNJ80316A , Lot Number:23LBE622 ; DYNJ80316A , Lot Number:24ABA118 ; DYNJ80316A , Lot Number:24ABQ972 ; DYNJ80316A , Lot Number:24BBL220 ; DYNJ80487A , Lot Number:22HBI178 ; DYNJ80487B , Lot Number:23BBR916 ; DYNJ80487B , Lot Number:23CBP361 ; DYNJ80487C , Lot Number:23FBO339 ; DYNJ80487C , Lot Number:23GBO642 ; DYNJ80487C , Lot Number:23GBR276 ; DYNJ80487C , Lot Number:23HBP753 ; DYNJ80487F , Lot Number:23KBF204 ; DYNJ80487F , Lot Number:23KBF967 ; DYNJ80487F , Lot Number:24BBJ804 ; DYNJ84265A , Lot Number:23LBP047 ; DYNJ84265A , Lot Number:24ABU345 ; DYNJ85332, Lot Number:23KBM469 ; LYN042CPFEG, Lot Number:21LBM245 ; VAL011CTASF, Lot Number:23CBI687 ; VAL011CTASF, Lot Number:23DBO423 ; VAL011CTASF, Lot Number:23FBD539 ; VAL011CTASF, Lot Number:23IBE673 ; VAL011CTASF, Lot Number:23KBC654 ; VAL011CTASF, Lot Number:23LBG127 ; DYNJ43048K , Lot Number:23JMF537 ; DYNJ52649D , Lot Number:21CMD757 ; DYNJ52649D , Lot Number:21HMD666 ; DYNJ52649F , Lot Number:23FMJ496 ; DYNJ52649F , Lot Number:23GMC382 ; DYNJ52649F , Lot Number:23HME435 ; DYNJ52649F , Lot Number:23KMF720 ; DYNJ52649F , Lot Number:23LMG694 ; DYNJ54790D , Lot Number:23AMB680 ; DYNJ55682D , Lot Number:23JMB655 ; DYNJ63284A , Lot Number:21HMA782 ; DYNJ63284A , Lot Number:22DME834 ; DYNJ63284A , Lot Number:23CMA698 ; DYNJ63284B , Lot Number:23GMH292 ; DYNJ63284B , Lot Number:23KMB077 ; DYNJ63284B , Lot Number:24AMB323 ; DYNJ64962, Lot Number:23KMH920 ; DYNJ66410B , Lot Number:23JMB324 ; DYNJ85042, Lot Number:23JMD316 ; DYNJ68836B , Lot Number:23KLA266 ; DYNJ68836B , Lot Number:23LLB070 ; DYNJ54790F , Lot Number:23JMC258 ; DYNJ54790F , Lot Number:23LMI220 ; DYNJ61699D , Lot Number:23HBI192 ; DYNJ80232, Lot Number:24ABL377 ; DYNJ80232H , Lot Number:24ABL377 ; DYNJ42830D , Lot Number:23IBA622 ; DYNJ0200004B , Lot Number:23GMI902 ; DYNJ36100C , Lot Number:22KMH152 ; DYNJ44356I , Lot Number:22FBL880 ; DYNJ44356I , Lot Number:22HBA943 ; DYNJ44356I , Lot Number:23BBL664 ; DYNJ44356I , Lot Number:23DBC100 ; DYNJ44356I , Lot Number:23FBK101 ; DYNJ44356J , Lot Number:23HBJ438 ; DYNJ44356J , Lot Number:23JBB906 ; DYNJ44356J , Lot Number:23LBA253 ; DYNJ44356J , Lot Number:24ABQ985 ; DYNJ44356J , Lot Number:24BBC038 ; DYNJ44356J , Lot Number:24BBL641 ; DYNJ62410A , Lot Number:23GBS482 ; DYNJ62410A , Lot Number:23HBN329 ; EYT102K, Lot Number:23IDA309 ; DYNJ66003D , Lot Number:24CBE592 ; DYNJ66003C , Lot Number:21FBK406 ; DYNJ66003C , Lot Number:21CBM686 ; DYNJ66003C , Lot Number:21DBT747 ; DYNJ66003D , Lot Number:22FBC039 ; DYNJ66003D , Lot Number:23JBE968 ; DYNJ66003D , Lot Number:23JBQ750 ; DYNJ66003D , Lot Number:24ABO688 ; DYNJ66003D , Lot Number:24BBG701 ; DYNJ66004B , Lot Number:24CBE607 ; DYNJ66004A , Lot Number:20LBE742 ; DYNJ66004B , Lot Number:21FBT041 ; DYNJ66004B , Lot Number:22EBR001 ; DYNJ66004B , Lot Number:22FBS391 ; DYNJ66004B , Lot Number:24BBL458 ; DYNJ19973S , Lot Number:23JME916 ; DYNJ57258G , Lot Number:23IBB036 ; DYNJ44671C , Lot Number:21HDB625 ; DYNJ44671D , Lot Number:22ADA848 ; DYNJ44671D , Lot Number:22CDA486 ; DYNJ0559863K , Lot Number:23LMA799 ; DYNJ37682J , Lot Number:23BMD927 ; DYNJ37682K , Lot Number:23HMD991 ; DYNJ63272B , Lot Number:23IBG537 ; MNS13080 , Lot Number:21DBC890 ; DYNJ66022A , Lot Number:23HBR314 ; DYNJ66022A , Lot Number:23HBR356 ; DYNJ63638A , Lot Number:23IBE732 ; DYNJ40135C , Lot Number:23GBW482 ; DYNJ55484A , Lot Number:21KBH827 ; DYNJ55484A , Lot Number:21LBO808 ; DYNJ55484A , Lot Number:22FBJ347 ; DYNJ55484A , Lot Number:23HBM901 ; DYNJ55484A , Lot Number:23IBR023 ; DYNJ60960A , Lot Number:23BBJ999 ; DYNJ60960A , Lot Number:23CBS340 ; DYNJ60960A , Lot Number:23EBD517 ; DYNJ60960A , Lot Number:23FBI464 ; DYNJ60960A , Lot Number:23GBM127 ; DYNJ67973B , Lot Number:24ABM354 ; DYNJ83799C , Lot Number:23HBM374 ; DYNJ83799C , Lot Number:23IBE242 ; VAL013EPWEC, Lot Number:23IBD749 ; VAL038BSCLC, Lot Number:21FBI402 ; VAL038BSCLC, Lot Number:22FBI684 ; VAL038BSCLC, Lot Number:22GBI953 ; VAL038BSCLC, Lot Number:22HBE695 ; VAL038BSCLC, Lot Number:22HBH463 ; VAL038BSCLC, Lot Number:23BBP414 ; VAL038BSCLC, Lot Number:23CBA206 ; VAL038BSCLC, Lot Number:23GBN565 ; VAL038BSCLC, Lot Number:23IBQ356 ; VAL038BSCLC, Lot Number:23JBQ925 ; VAL038BSCLC, Lot Number:20IBH345 ; VAL038BSCLC, Lot Number:24ABL864 ; VAL038BSCLC, Lot Number:24BBP892 ; VAL038BSCLC, Lot Number:20LBY788 ; VAL038BSCLC, Lot Number:21CBV826 ; VAL038BSCLC, Lot Number:21FBE159 ; DYNJ56293D , Lot Number:23IDB161 ; DYNJ64051C , Lot Number:23CDC473 ; DYNJ64051C , Lot Number:23GDA852 ; CMPJ06528F , Lot Number:23KMA165 ; DYNJ38400I , Lot Number:21IMA857 ; DYNJ38400I , Lot Number:21IMH583 ; DYNJ38400I , Lot Number:22DMD856 ; DYNJ38400J , Lot Number:23KMG804 ; DYNJ60960A , Lot Number:22EMA599 ; DYNJ64284C , Lot Number:21HMA162 ; DYNJ64284C , Lot Number:23CMA702 ; DYNJ64284D , Lot Number:23FMJ780 ; DYNJ64284D , Lot Number:23KMD668 ; DYNJ64284D , Lot Number:23LMD080 ; DYNJ64284D , Lot Number:24AMG449 ; DYNJ64051D , Lot Number:23LLA491 ; VAL013EPFEG, Lot Number:23IBQ281 ; VAL013EPFEI, Lot Number:23LBH694 ; DYNJ63096A , Lot Number:23FBC693 ; DYNJ63096A , Lot Number:23GBW469 ; DYNJ0516258W , Lot Number:23KMB305 ; DYNJ0559777C , Lot Number:21HMC030 ; DYNJ0559777C , Lot Number:22CMH758 ; DYNJ0559777D , Lot Number:23EMK184 ; DYNJ0559777F , Lot Number:23GMG783 ; DYNJ0559777F , Lot Number:23JME881 ; DYNJ0559777F , Lot Number:23KMB427 ; DYNJ0559777F , Lot Number:24AMB790 ; DYNJ53097C , Lot Number:23IBE728 ; DYNJ27580F , Lot Number:22OBG462 ; DYNJ27580F , Lot Number:22FBR432 ; DYNJ27580F , Lot Number:22GBX560 ; DYNJ27580F , Lot Number:22JBE628 ; DYNJ27580F , Lot Number:22JBT093 ; DYNJ27580F , Lot Number:23BBO703 ; DYNJ27580G , Lot Number:23CBP779 ; DYNJ27580G , Lot Number:23DBS205 ; DYNJ27580G , Lot Number:23FBC630 ; DYNJ27580G , Lot Number:23GBC544 ; DYNJ27580G , Lot Number:23HBM937 ; DYNJ27580G , Lot Number:23KBQ070 ; DYNJ21627L , Lot Number:24AMF970 ; DYNJ81183A , Lot Number:22GBM466 ; DYNJ53678B , Lot Number:21LBJ879 ; DYNJ53678B , Lot Number:22FBY588 ; DYNJ53678B , Lot Number:22IBQ735 ; DYNJ53678B , Lot Number:23BBQ152 ; DYNJ53678B , Lot Number:23HBP513 ; DYNJ66038A , Lot Number:23HBT377 ; DYNJ0608576P , Lot Number:23JME914 ; DYNJ67519A , Lot Number:23HBT970 ; DYNJ67519A , Lot Number:23IBE623 ; DYNJ902885D, Lot Number:23IBD838 ; DYNJ902885D, Lot Number:23IBD935 ; DYNJ902885D, Lot Number:23IBM274 ; DYNJ54393D , Lot Number:23HBK063 ; DYNJ34288K , Lot Number:22OBB445 ; DYNJ34288K , Lot Number:22GBF074 ; DYNJ34288K , Lot Number:22HBK556 ; DYNJ34288K , Lot Number:23CBC625 ; DYNJ38109C , Lot Number:21KBT541 ; DYNJ38109C , Lot Number:21LBK050 ; DYNJ38109C , Lot Number:22IBS327 ; DYNJ38109C , Lot Number:23BBA458 ; DYNJ38109C , Lot Number:23GBF633 ; DYNJ38109C , Lot Number:23GBI442 ; DYNJ38109C , Lot Number:23IBC961 ; DYNJ67973A , Lot Number:22JBK486 ; DYNJ67973A , Lot Number:23ABM186 ; DYNJ67973A , Lot Number:23GBI608 ; DYNJ67973A , Lot Number:23IBC924 ; DYNJ55840A , Lot Number:21GMD889 ; DYNJ55840A , Lot Number:21IMC582 ; DYNJ55840A , Lot Number:22AMC428 ; DYNJ55840A , Lot Number:22CMH721 ; DYNJ55840A , Lot Number:23FMJ603 ; DYNJ55840A , Lot Number:23KMC842 ; DYNJ82201, Lot Number:23IDA107 ; DYNJ901206D, Lot Number:22HBW709 ; DYNJ901206D, Lot Number:23DBP697 ; CMPJ05506D , Lot Number:22HBH563 ; CMPJ05506D , Lot Number:23CBH848 ; DYNJ65156A , Lot Number:23KDA430 ; DYNJ47273I , Lot Number:22LMD338 ; DYNJ80556C , Lot Number:24ABL912 ; DYNJ60631B , Lot Number:23HBP777 ; DYNJ60631B , Lot Number:23HBZ160 ; DYNJVB91043A , Lot Number:23JDC086 ; DYNJVB91043A , Lot Number:23KDB345 ; CMPJ11101, Lot Number:23IDB922 ; CMPJ11101, Lot Number:23JDA637 ; DYNJ42845D , Lot Number:23IBA707 ; DYNJ44507J , Lot Number:23HBV391 ; DYNJ85449, Lot Number:24ABD671 ; DYNJ57970C , Lot Number:23CBS337 ; DYNJ57970C , Lot Number:23DBB080 ; DYNJ57970D , Lot Number:23JBT640 ; DYNJ57970D , Lot Number:23KBN028 ; DYNJ57970D , Lot Number:24ABB977 ; DYNJ57970D , Lot Number:24ABV141 ; DYNJ34159D , Lot Number:23HBV666 ; DYNJ80483, Lot Number:24ABK886 ; DYNJ66624A , Lot Number:23GMG818 ; DYNJ81824, Lot Number:23HBP061 ; DYNJ68627, Lot Number:21CBM277 ; DYNJ68627B , Lot Number:23IBC749 ; DYNJ68627B , Lot Number:23GMB879 ; DYNJ68627C , Lot Number:24AMB768 ; DYNJ43818, Lot Number:22AMD337 ; DYNJ43818, Lot Number:23BMC400 ; DYNJ43818, Lot Number:23GMI178 ; DYNJ43818, Lot Number:23JMK100 ; CMPJ21591J , Lot Number:23HBI095 ; DYNJ60021A , Lot Number:23HBT040 ; DYNJ43050N , Lot Number:23JMG418 ; CDS810023J , Lot Number:23HBV221 ; DYNJ900374N, Lot Number:22FBB171 ; DYNJ900374N, Lot Number:22FBC598 ; DYNJ900374N, Lot Number:22HBV856 ; CMPJ04908M , Lot Number:22EBF948 ; CMPJ04908M , Lot Number:22HBK544 ; DYNJ83503, Lot Number:23CMC327 ; DYNJ83503, Lot Number:23GMD280 ; DYNJ83503, Lot Number:23JMF577 ; DYNJ53853F , Lot Number:23KMB732 ; DYNJ20988G , Lot Number:21JMG468 ; DYNJ20988G , Lot Number:22AME490 ; DYNJ20988G , Lot Number:22CMA075 ; DYNJ20988G , Lot Number:22DME734 ; DYNJ20988G , Lot Number:22FMA831 ; DYNJ20988G , Lot Number:22GMC750 ; DYNJ20988G , Lot Number:22HMC747 ; DYNJ20988G , Lot Number:22IME434 ; DYNJ20988G , Lot Number:22LMD535 ; DYNJ37739L , Lot Number:23IBE128 ; DYNJ40839A , Lot Number:23KMC318 ; DYNJ40839A , Lot Number:24AMF192 ; DYNJ80114, Lot Number:21KMD689 ; DYNJ80114, Lot Number:22AMF833 ; DYNJ80114, Lot Number:22DMD369 ; DYNJ80114A , Lot Number:23BMB820 ; DYNJ80114A , Lot Number:23FMF556 ; DYNJ80114A , Lot Number:23GMD277 ; DYNJ80114A , Lot Number:23HMB645 ; DYNJ80114A , Lot Number:23HMH770 ; DYNJ80114A , Lot Number:23JMD209 ; DYNJ80114A , Lot Number:23KMB513 ; DYNJ80114A , Lot Number:23LMA560 ; VAL043VPASC, Lot Number:21LBR917 ; DYNJVB1080A, Lot Number:23IDA988 ; DYNJ55508B , Lot Number:22KBF091 ; DYNJ55508B , Lot Number:23BBI775 ; DYNJ55508B , Lot Number:23CBB250 ; DYNJ55508B , Lot Number:23EBB305 ; DYNJ55508B , Lot Number:23EBV036 ; DYNJ55508B , Lot Number:24ABW624 ; DYNJ55508B , Lot Number:24BBR693 ; DYNDA2857, Lot Number:22JME670 ; DYNDA2857A , Lot Number:23GME382 ; DYNDA2857A , Lot Number:23JMG571 ; DYNJ38495J , Lot Number:23HMG757 ; DYNJ0843936F , Lot Number:22ADB686 ; DYNJ0843936F , Lot Number:22JDA822 ; DYNJ0843936G , Lot Number:22KDB025 ; DYNJ0843936G , Lot Number:23ADA378 ; DYNJ0843936I , Lot Number:23JDA380 ; DYNJ46536F , Lot Number:21DMA451 ; DYNJ46536F , Lot Number:21FMA586 ; DYNJ46536F , Lot Number:21IMB516 ; DYNJ46536G , Lot Number:22AMD760 ; DYNJ46536G , Lot Number:22CMH930 ; DYNJ46536G , Lot Number:22DMC362 ; DYNJ46536G , Lot Number:22DMF054 ; DYNJ46536G , Lot Number:23EMJ440 ; DYNJ46536I , Lot Number:23GMI800 ; DYNJ82153, Lot Number:22ILA613 ; DYNJ82153, Lot Number:23DLA980 ; DYNJ82153, Lot Number:24BLB069
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
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-08
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 409 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2764-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
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EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
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