| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
|---|
| Date Posted | August 28, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2764-2024 |
|---|
| Recall Event ID |
94581 |
| Product Classification |
Eye tray - Product Code OJK
|
| Product | 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 |
|---|
| Code Information |
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 |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Karin Johnson
886-359-1704 |
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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. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| 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 the 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. |
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| Distribution | Worldwide |
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| Total Product Life Cycle | TPLC Device Report |
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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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