| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | April 08, 2024 |
|---|
| Date Posted | September 06, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-3012-2024 |
|---|
| Recall Event ID |
94583 |
| Product Classification |
Foley catheter kit (excludes HIV testing) - Product Code PPB
|
| Product | Medline Convenience kits labeled as:
1) GB GENERAL ENDO , Pack Number CDS984155G ;
2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B;
3) ENDO KIT, Pack Number DYKE1487C;
4) BRONCH ENDO W/O BEDSIDE KIT , Pack Number DYKE1634 ;
5) ENDO KIT, Pack Number DYKE1696 ;
6) PULMONARY ENDO KIT, Pack Number DYKE1713 ;
7) ENDO KIT, Pack Number DYKE1739 ;
8) ENDOSCOPY PACK-LF , Pack Number DYNJ00339K ;
9) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ0190667K ;
10) CH UMBIL CATH W/INSTR PACK-LF, Pack Number DYNJ0622040Q;
11) ENDOSCOPY-LF, Pack Number DYNJ22890M ;
12) ENDOSCOPIC PACK , Pack Number DYNJ30434I ;
13) ENDOSCOPIC SINUS PACK , Pack Number DYNJ40644A ;
14) ENDOSCOPY PACK, Pack Number DYNJ40645B;
15) ENDO SURGICAL PACK WRO-LF , Pack Number DYNJ41870B ;
16) ENT PK 1008847, Pack Number DYNJ42319C ;
17) ENDOVENOUS BASIC PACK , Pack Number DYNJ42456D ;
18) UROLOGY ENDOSCOPE PACK 319738 , Pack Number DYNJ44638C ;
19) ENDOSCOPY PACK-LF , Pack Number DYNJ53271C ;
20) ENDOSCOPY , Pack Number DYNJ62133;
21) ENDOSCOPY PACK, Pack Number DYNJ62193;
22) ENDOVENOUS CORE PACK, Pack Number DYNJ62557;
23) ENDOSCOPY PACK, Pack Number DYNJ62914;
24) ENDOSCOPIC PACK , Pack Number DYNJ63797A ;
25) ENDOVENOUS ABLATION PACK, Pack Number DYNJ64059;
26) GENERAL ENDOSCOPY PACK, Pack Number DYNJ65371;
27) GYN ENDOSCOPY PACK, Pack Number DYNJ65372;
28) CV NEONATAL PACK, Pack Number DYNJ67356;
29) PEDI ENDO LAP PACK, Pack Number DYNJ68141A ;
30) ENSEMBLE CATHETER DIALYSE-LF, Pack Number DYNJ81973;
31) ENT , Pack Number DYNJ900282I;
32) MUH ENDOCRINE , Pack Number DYNJ901706J;
33) SEPTO/ENDO, Pack Number DYNJ902831D;
34) MODULE ENDO LAP , Pack Number DYNJ903026I;
35) CVOR ENDOSTENT, Pack Number DYNJ906465 ;
36) ENDOSCOPIC SKULL BASE , Pack Number DYNJ906630 ;
37) ENDO CHOLE TRAY , Pack Number LZ7759N;
38) CATHETERIZATION TRAY, Pack Number UVT1175;
39) UMBILICAL VESSEL INSERTION TRA, Pack Number UVT730;
40) TVS4000 ENDOVENOUS PACK, Pack Number TVS4000K |
|---|
| Code Information |
CDS984155G , Lot Number 21GBT672 ;
CDS984155G , Lot Number 21JBH429 ;
CDS984155G , Lot Number 21LBP590 ;
CDS984155G , Lot Number 22CBJ567 ;
CDS984155G , Lot Number 22FBB170 ;
CDS984155G , Lot Number 22GBB172 ;
CDS984155G , Lot Number 22GBW487 ;
CDS984155G , Lot Number 22HBN079 ;
CDS984155G , Lot Number 22IBR934 ;
CDS984155G , Lot Number 19LBO258 ;
CDS984155G , Lot Number 20BBE301 ;
CDS984155G , Lot Number 20EBC706 ;
CDS984155G , Lot Number 20EBS188 ;
CDS984155G , Lot Number 20GBA894 ;
CDS984155G , Lot Number 20IBD347 ;
CDS984155G , Lot Number 20JBK812 ;
CDS984155G , Lot Number 21BBO717 ;
CDS984155G , Lot Number 21EBO578 ;
DYKE1455B, Lot Number 20GBI602 ;
DYKE1487C, Lot Number 22GMD695 ;
DYKE1634 , Lot Number 19DAA540 ;
DYKE1634 , Lot Number 19DAB449 ;
DYKE1634 , Lot Number 19JAA076 ;
DYKE1634 , Lot Number 21LBY138 ;
DYKE1634 , Lot Number 22ABW321 ;
DYKE1634 , Lot Number 22IBN133 ;
DYKE1634 , Lot Number 23ABN492 ;
DYKE1634 , Lot Number 23EBE760 ;
DYKE1634 , Lot Number 20BBY787 ;
DYKE1634 , Lot Number 23FBP558 ;
DYKE1634 , Lot Number 20EBI139 ;
DYKE1634 , Lot Number 23KBU935 ;
DYKE1634 , Lot Number 20HBM035 ;
DYKE1634 , Lot Number 20IBS530 ;
DYKE1634 , Lot Number 20JBF837 ;
DYKE1696 , Lot Number 23LMF046 ;
DYKE1713 , Lot Number 22ABU757 ;
DYKE1713 , Lot Number 22BBY210 ;
DYKE1713 , Lot Number 22GBJ615 ;
DYKE1713 , Lot Number 22KBC587 ;
DYKE1713 , Lot Number 19JBJ509 ;
DYKE1713 , Lot Number 23BBL166 ;
DYKE1713 , Lot Number 23BBU192 ;
DYKE1713 , Lot Number 23EBA547 ;
DYKE1713 , Lot Number 20BBA308 ;
DYKE1713 , Lot Number 23FBT851 ;
DYKE1713 , Lot Number 20CBW284 ;
DYKE1713 , Lot Number 20DBU069 ;
DYKE1713 , Lot Number 23JBY319 ;
DYKE1713 , Lot Number 23KBI749 ;
DYKE1713 , Lot Number 20IBD604 ;
DYKE1713 , Lot Number 20IBD920 ;
DYKE1713 , Lot Number 21BBR876 ;
DYKE1713 , Lot Number 21CBZ238 ;
DYKE1713 , Lot Number 21EBI062 ;
DYKE1713 , Lot Number 21EBI179 ;
DYKE1739 , Lot Number 21FBI996 ;
DYKE1739 , Lot Number 20ABX716 ;
DYKE1739 , Lot Number 20DBC649 ;
DYKE1739 , Lot Number 20GBJ601 ;
DYKE1739 , Lot Number 20HBB784 ;
DYKE1739 , Lot Number 20HBK727 ;
DYKE1739 , Lot Number 20HBS038 ;
DYKE1739 , Lot Number 20IBC158 ;
DYKE1739 , Lot Number 20JBU785 ;
DYKE1739 , Lot Number 20KBC347 ;
DYKE1739 , Lot Number 21CBK025 ;
DYKE1739 , Lot Number 21GMB307 ;
DYKE1739 , Lot Number 21HMF607 ;
DYKE1739 , Lot Number 21JMF960 ;
DYKE1739 , Lot Number 21KMG583 ;
DYKE1739 , Lot Number 21LMF454 ;
DYKE1739 , Lot Number 22DMB064 ;
DYKE1739 , Lot Number 22EMH721 ;
DYKE1739 , Lot Number 22IMC388 ;
DYKE1739 , Lot Number 23BMC773 ;
DYKE1739 , Lot Number 23GMA887 ;
DYKE1739 , Lot Number 23HMB551 ;
DYKE1739 , Lot Number 23HMH146 ;
DYKE1739 , Lot Number 23IMD762 ;
DYKE1739 , Lot Number 23JMB830 ;
DYKE1739 , Lot Number 23LMB870 ;
DYNJ00339K , Lot Number 20FMB927 ;
DYNJ00339K , Lot Number 20IMD268 ;
DYNJ00339K , Lot Number 20JMA687 ;
DYNJ00339K , Lot Number 20KME960 ;
DYNJ00339K , Lot Number 21FMF410 ;
DYNJ00339K , Lot Number 21GMD690 ;
DYNJ00339K , Lot Number 21IMC817 ;
DYNJ00339K , Lot Number 21JMB868 ;
DYNJ00339K , Lot Number 21JMI001 ;
DYNJ00339K , Lot Number 21KMG647 ;
DYNJ00339K , Lot Number 22DMI651 ;
DYNJ00339K , Lot Number 22FMH268 ;
DYNJ00339K , Lot Number 22HMF938 ;
DYNJ00339K , Lot Number 22KMB969 ;
DYNJ00339K , Lot Number 23AMH189 ;
DYNJ00339K , Lot Number 23CMB223 ;
DYNJ00339K , Lot Number 23DMB072 ;
DYNJ00339K , Lot Number 23EMG067 ;
DYNJ00339K , Lot Number 23GMI435 ;
DYNJ00339K , Lot Number 23IMG664 ;
DYNJ00339K , Lot Number 23KMB549 ;
DYNJ00339K , Lot Number 23LMG313 ;
DYNJ0190667K , Lot Number 19EBD072 ;
DYNJ0190667K , Lot Number 19FBA123 ;
DYNJ0190667K , Lot Number 19FBA366 ;
DYNJ0190667K , Lot Number 19HBT841 ;
DYNJ0190667K , Lot Number 19JBD387 ;
DYNJ0190667K , Lot Number 19KBT463 ;
DYNJ0190667K , Lot Number 20ABT003 ;
DYNJ0190667K , Lot Number 20CBQ483 ;
DYNJ0190667K , Lot Number 20EBN290 ;
DYNJ0190667K , Lot Number 20GBO262 ;
DYNJ0190667K , Lot Number 20JBN166 ;
DYNJ0190667K , Lot Number 21ABT922 ;
DYNJ0190667K , Lot Number 21CBD760 ;
DYNJ0190667K , Lot Number 21DBO473 ;
DYNJ0190667K , Lot Number 21EME899 ;
DYNJ0190667K , Lot Number 21GME698 ;
DYNJ0190667K , Lot Number 21IMC659 ;
DYNJ0190667K , Lot Number 21LMG066 ;
DYNJ0190667K , Lot Number 22AMB738 ;
DYNJ0190667K , Lot Number 22BMG712 ;
DYNJ0190667K , Lot Number 22CME680 ;
DYNJ0190667K , Lot Number 22DMB770 ;
DYNJ0190667K , Lot Number 22FMA583 ;
DYNJ0190667K , Lot Number 22HMA944 ;
DYNJ0190667K , Lot Number 22IMD456 ;
DYNJ0190667K , Lot Number 22LMC230 ;
DYNJ0190667K , Lot Number 23AMH577 ;
DYNJ0190667K , Lot Number 23AMI382 ;
DYNJ0190667K , Lot Number 23CMD624 ;
DYNJ0190667K , Lot Number 23DMC091 ;
DYNJ0190667K , Lot Number 23EME584 ;
DYNJ0190667K , Lot Number 23FMD211 ;
DYNJ0190667K , Lot Number 23GMF632 ;
DYNJ0190667K , Lot Number 23HME743 ;
DYNJ0190667K , Lot Number 23IMG608 ;
DYNJ0190667K , Lot Number 23JMH633 ;
DYNJ0190667K , Lot Number 23LMF564 ;
DYNJ0622040Q, Lot Number 24BLA601;
DYNJ0622040Q, Lot Number 24ALA070;
DYNJ0622040Q, Lot Number 23HLA750;
DYNJ0622040Q, Lot Number 23ALA491;
DYNJ0622040Q, Lot Number 22JLA277;
DYNJ0622040Q, Lot Number 22ILB030;
DYNJ0622040Q, Lot Number 22ILA821;
DYNJ0622040Q, Lot Number 22ILA226;
DYNJ0622040Q, Lot Number 22HLA876;
DYNJ22890M , Lot Number 21JBX107 ;
DYNJ22890M , Lot Number 21KBO873 ;
DYNJ22890M , Lot Number 21KBO877 ;
DYNJ22890M , Lot Number 22ABJ346 ;
DYNJ22890M , Lot Number 19HBM059 ;
DYNJ22890M , Lot Number 22JBM081 ;
DYNJ22890M , Lot Number 19IBT334 ;
DYNJ22890M , Lot Number 19KBS750 ;
DYNJ22890M , Lot Number 19KBW317 ;
DYNJ22890M , Lot Number 23DBM600 ;
DYNJ22890M , Lot Number 20BBG920 ;
DYNJ22890M , Lot Number 20CBQ486 ;
DYNJ22890M , Lot Number 21BBB024 ;
DYNJ22890M , Lot Number 21BBE213 ;
DYNJ30434I , Lot Number 19FBC091 ;
DYNJ30434I , Lot Number 19FBO586 ;
DYNJ30434I , Lot Number 19HBT794 ;
DYNJ30434I , Lot Number 19JBL207 ;
DYNJ30434I , Lot Number 19JMA742 ;
DYNJ30434I , Lot Number 20AMA906 ;
DYNJ30434I , Lot Number 20BMB432 ;
DYNJ30434I , Lot Number 20BMB950 ;
DYNJ30434I , Lot Number 20CMB292 ;
DYNJ30434I , Lot Number 20HMA247 ;
DYNJ30434I , Lot Number 20HMD625 ;
DYNJ30434I , Lot Number 20IMC739 ;
DYNJ30434I , Lot Number 21AME134 ;
DYNJ30434I , Lot Number 21BME286 ;
DYNJ30434I , Lot Number 21CME244 ;
DYNJ30434I , Lot Number 21EMC851 ;
DYNJ30434I , Lot Number 21FMD635 ;
DYNJ30434I , Lot Number 21HME258 ;
DYNJ30434I , Lot Number 21IMA388 ;
DYNJ30434I , Lot Number 21JMD320 ;
DYNJ30434I , Lot Number 21KMF781 ;
DYNJ30434I , Lot Number 22AMB792 ;
DYNJ30434I , Lot Number 22FMH427 ;
DYNJ40644A , Lot Number 20CMB952 ;
DYNJ40644A , Lot Number 20HMB559 ;
DYNJ40644A , Lot Number 20KMA468 ;
DYNJ40644A , Lot Number 20KMB182 ;
DYNJ40644A , Lot Number 20KMC866 ;
DYNJ40644A , Lot Number 21AME524 ;
DYNJ40644A , Lot Number 21DMA759 ;
DYNJ40644A , Lot Number 21EME248 ;
DYNJ40644A , Lot Number 21GMB592 ;
DYNJ40644A , Lot Number 21HMC615 ;
DYNJ40644A , Lot Number 21IMF418 ;
DYNJ40644A , Lot Number 21JMA505 ;
DYNJ40644A , Lot Number 21KMG859 ;
DYNJ40644A , Lot Number 21LMF984 ;
DYNJ40645B, Lot Number 22AMD386;
DYNJ40645B, Lot Number 21LMC822;
DYNJ40645B, Lot Number 21JMF409;
DYNJ40645B, Lot Number 21IMC184;
DYNJ40645B, Lot Number 21GMB555;
DYNJ41870B , Lot Number 21FBS263 ;
DYNJ41870B , Lot Number 21GBJ652 ;
DYNJ41870B , Lot Number 21IBC888 ;
DYNJ41870B , Lot Number 22BBJ487 ;
DYNJ41870B , Lot Number 22BBJ492 ;
DYNJ41870B , Lot Number 22BBR105 ;
DYNJ41870B , Lot Number 19EBN573 ;
DYNJ41870B , Lot Number 19FBB623 ;
DYNJ41870B , Lot Number 19FBC317 ;
DYNJ41870B , Lot Number 22GBU057 ;
DYNJ41870B , Lot Number 22JBQ322 ;
DYNJ41870B , Lot Number 23ABG049 ;
DYNJ41870B , Lot Number 19VBD185 ;
DYNJ41870B , Lot Number 23BBU327 ;
DYNJ41870B , Lot Number 23BBU418 ;
DYNJ41870B , Lot Number 19WBA041 ;
DYNJ41870B , Lot Number 20BBF643 ;
DYNJ41870B , Lot Number 20CBX489 ;
DYNJ41870B , Lot Number 20DBQ198 ;
DYNJ41870B , Lot Number 20EBE927 ;
DYNJ41870B , Lot Number 20EBG738 ;
DYNJ41870B , Lot Number 20FBF015 ;
DYNJ42319C , Lot Number 21KBD492 ;
DYNJ42319C , Lot Number 21LBG900 ;
DYNJ42319C , Lot Number 22ABA711 ;
DYNJ42319C , Lot Number 22BBT747 ;
DYNJ42319C , Lot Number 22OBB494 ;
DYNJ42319C , Lot Number 20ABA663 ;
DYNJ42319C , Lot Number 20ABV158 ;
DYNJ42319C , Lot Number 20ABV758 ;
DYNJ42319C , Lot Number 20GBG214 ;
DYNJ42319C , Lot Number 20KBZ302 ;
DYNJ42319C , Lot Number 21ABL492 ;
DYNJ42319C , Lot Number 21CBY739 ;
DYNJ42319C , Lot Number 21EBS624 ;
DYNJ42319C , Lot Number 22KMB384 ;
DYNJ42319C , Lot Number 23CMD967 ;
DYNJ42319C , Lot Number 23EMB306 ;
DYNJ42319C , Lot Number 23FMD067 ;
DYNJ42456D , Lot Number 19GBR109 ;
DYNJ44638C , Lot Number 19JBB386 ;
DYNJ44638C , Lot Number 19LBT942 ;
DYNJ44638C , Lot Number 20DBC586 ;
DYNJ44638C , Lot Number 20FBG227 ;
DYNJ44638C , Lot Number 21BBR819 ;
DYNJ44638C , Lot Number 21DBI082 ;
DYNJ44638C , Lot Number 21EBA653 ;
DYNJ53271C , Lot Number 21GBP921 ;
DYNJ53271C , Lot Number 21JBV143 ;
DYNJ53271C , Lot Number 21KBX450 ;
DYNJ53271C , Lot Number 22ABX479 ;
DYNJ53271C , Lot Number 22CBJ797 ;
DYNJ53271C , Lot Number 19CBK323 ;
DYNJ53271C , Lot Number 22DBQ303 ;
DYNJ53271C , Lot Number 22DBS472 ;
DYNJ53271C , Lot Number 19DBP816 ;
DYNJ53271C , Lot Number 19EBP637 ;
DYNJ53271C , Lot Number 19FBR626 ;
DYNJ53271C , Lot Number 22GBV025 ;
DYNJ53271C , Lot Number 22HBD540 ;
DYNJ53271C , Lot Number 19HBR716 ;
DYNJ53271C , Lot Number 22JBJ775 ;
DYNJ53271C , Lot Number 22JBX045 ;
DYNJ53271C , Lot Number 22LBE488 ;
DYNJ53271C , Lot Number 19JBE895 ;
DYNJ53271C , Lot Number 23BBA553 ;
DYNJ53271C , Lot Number 19LBD484 ;
DYNJ53271C , Lot Number 23CBI223 ;
DYNJ53271C , Lot Number 23DBK795 ;
DYNJ53271C , Lot Number 23EBS925 ;
DYNJ53271C , Lot Number 20BBI657 ;
DYNJ53271C , Lot Number 23GBH019 ;
DYNJ53271C , Lot Number 20CBR785 ;
DYNJ53271C , Lot Number 23HBU868 ;
DYNJ53271C , Lot Number 20FBF734 ;
DYNJ53271C , Lot Number 23JBD689 ;
DYNJ53271C , Lot Number 23KBG525 ;
DYNJ53271C , Lot Number 20HBE090 ;
DYNJ53271C , Lot Number 23LBU090 ;
DYNJ53271C , Lot Number 20JBL759 ;
DYNJ53271C , Lot Number 20LBI588 ;
DYNJ53271C , Lot Number 21CBE721 ;
DYNJ53271C , Lot Number 21EBA973 ;
DYNJ62133, Lot Number 21KBD805 ;
DYNJ62133, Lot Number 21KBP864 ;
DYNJ62133, Lot Number 21LBQ348 ;
DYNJ62133, Lot Number 22BBO070 ;
DYNJ62133, Lot Number 22DBM856 ;
DYNJ62133, Lot Number 22DBN285 ;
DYNJ62133, Lot Number 22FBY593 ;
DYNJ62133, Lot Number 22IBQ159 ;
DYNJ62133, Lot Number 22JBG314 ;
DYNJ62133, Lot Number 22KBR310 ;
DYNJ62133, Lot Number 22LBK846 ;
DYNJ62133, Lot Number 23BBF608 ;
DYNJ62133, Lot Number 23BBQ891 ;
DYNJ62133, Lot Number 23CBW335 ;
DYNJ62133, Lot Number 23EBD781 ;
DYNJ62133, Lot Number 23FBC879 ;
DYNJ62133, Lot Number 23HBT273 ;
DYNJ62133, Lot Number 23KBD907 ;
DYNJ62133, Lot Number 23LBA384 ;
DYNJ62133, Lot Number 24ABU004 ;
DYNJ62193, Lot Number 19CDC012 ;
DYNJ62193, Lot Number 19EDC720 ;
DYNJ62193, Lot Number 19IDA133 ;
DYNJ62193, Lot Number 19KDB481 ;
DYNJ62193, Lot Number 19LDC402 ;
DYNJ62193, Lot Number 20BDB103 ;
DYNJ62193, Lot Number 20CDB344 ;
DYNJ62193, Lot Number 20DDA727 ;
DYNJ62193, Lot Number 20EDA231 ;
DYNJ62193, Lot Number 20FDA990 ;
DYNJ62193, Lot Number 20IDA148 ;
DYNJ62193, Lot Number 21BDB558 ;
DYNJ62193, Lot Number 21CDB970 ;
DYNJ62193, Lot Number 21DDB909 ;
DYNJ62193, Lot Number 21GDC987 ;
DYNJ62193, Lot Number 21IDA663 ;
DYNJ62193, Lot Number 21JDA231 ;
DYNJ62193, Lot Number 22ADC044 ;
DYNJ62193, Lot Number 22CDB671 ;
DYNJ62193, Lot Number 22FDA335 ;
DYNJ62193, Lot Number 22JDB980 ;
DYNJ62193, Lot Number 22LDA838 ;
DYNJ62193, Lot Number 23EDA992 ;
DYNJ62193, Lot Number 23HDC112 ;
DYNJ62193, Lot Number 23KDA296 ;
DYNJ62193, Lot Number 23LDC017 ;
DYNJ62557, Lot Number 21KBP213 ;
DYNJ62557, Lot Number 21KBP214 ;
DYNJ62557, Lot Number 22EBP232 ;
DYNJ62557, Lot Number 19EBA543 ;
DYNJ62557, Lot Number 19FBR248 ;
DYNJ62557, Lot Number 22IBJ134 ;
DYNJ62557, Lot Number 19HBU100 ;
DYNJ62557, Lot Number 23DBL319 ;
DYNJ62557, Lot Number 23FBK195 ;
DYNJ62557, Lot Number 23HBX523 ;
DYNJ62557, Lot Number 24ABV094 ;
DYNJ62557, Lot Number 21CBH656 ;
DYNJ62557, Lot Number 21CBN805 ;
DYNJ62557, Lot Number 21CBP207 ;
DYNJ62914, Lot Number 20IDA187 ;
DYNJ63797A , Lot Number 21FBQ010 ;
DYNJ63797A , Lot Number 21GBC877 ;
DYNJ63797A , Lot Number 21GBC878 ;
DYNJ63797A , Lot Number 21JBV038 ;
DYNJ63797A , Lot Number 21JBV052 ;
DYNJ63797A , Lot Number 22BBG658 ;
DYNJ63797A , Lot Number 22DBL173 ;
DYNJ63797A , Lot Number 22FBE046 ;
DYNJ63797A , Lot Number 22FBX492 ;
DYNJ63797A , Lot Number 22HBI987 ;
DYNJ63797A , Lot Number 22IBS012 ;
DYNJ63797A , Lot Number 19KBP187 ;
DYNJ63797A , Lot Number 20ABS264 ;
DYNJ63797A , Lot Number 20ABW029 ;
DYNJ63797A , Lot Number 20BBY486 ;
DYNJ63797A , Lot Number 20EBT332 ;
DYNJ63797A , Lot Number 20EBU489 ;
DYNJ63797A , Lot Number 20FBP920 ;
DYNJ63797A , Lot Number 20GBB353 ;
DYNJ63797A , Lot Number 20GBP937 ;
DYNJ63797A , Lot Number 20HBR957 ;
DYNJ63797A , Lot Number 20IBO142 ;
DYNJ63797A , Lot Number 20KBR758 ;
DYNJ63797A , Lot Number 21CBA533 ;
DYNJ63797A , Lot Number 21CBT014 ;
DYNJ64059, Lot Number 19IBS257 ;
DYNJ64059, Lot Number 20ABR471 ;
DYNJ64059, Lot Number 20BBA528 ;
DYNJ65371, Lot Number 21HBM423 ;
DYNJ65371, Lot Number 21IBI691 ;
DYNJ65371, Lot Number 21IBV409 ;
DYNJ65371, Lot Number 22ABE873 ;
DYNJ65371, Lot Number 22ABN289 ;
DYNJ65371, Lot Number 22CBJ787 ;
DYNJ65371, Lot Number 22OBH515 ;
DYNJ65371, Lot Number 22FBN339 ;
DYNJ65371, Lot Number 22GBH478 ;
DYNJ65371, Lot Number 20BBP676 ;
DYNJ65371, Lot Number 20GBS807 ;
DYNJ65371, Lot Number 20GBT451 ;
DYNJ65371, Lot Number 20JBB071 ;
DYNJ65371, Lot Number 20JBG719 ;
DYNJ65371, Lot Number 20LBY530 ;
DYNJ65371, Lot Number 21BBI536 ;
DYNJ65371, Lot Number 21EBB482 ;
DYNJ65371, Lot Number 22HMG325 ;
DYNJ65371, Lot Number 22HMG333 ;
DYNJ65371, Lot Number 22JME136 ;
DYNJ65371, Lot Number 22JME143 ;
DYNJ65371, Lot Number 23AMD834 ;
DYNJ65371, Lot Number 23CMF481 ;
DYNJ65371, Lot Number 23DMI706 ;
DYNJ65372, Lot Number 22OBE240 ;
DYNJ65372, Lot Number 20BBR012 ;
DYNJ65372, Lot Number 20HBR404 ;
DYNJ65372, Lot Number 20IBJ748 ;
DYNJ65372, Lot Number 20JBR868 ;
DYNJ67356, Lot Number 21FBL509 ;
DYNJ67356, Lot Number 21LBC407 ;
DYNJ67356, Lot Number 21LBQ690 ;
DYNJ67356, Lot Number 22EMB961 ;
DYNJ67356, Lot Number 22FMD091 ;
DYNJ67356, Lot Number 22HMB876 ;
DYNJ67356, Lot Number 22JMD170 ;
DYNJ67356, Lot Number 22LMA801 ;
DYNJ67356, Lot Number 23CME409 ;
DYNJ67356, Lot Number 23DMD150 ;
DYNJ67356, Lot Number 23EMF480 ;
DYNJ67356, Lot Number 23FMG621 ;
DYNJ67356, Lot Number 23FMH061 ;
DYNJ67356, Lot Number 23FMJ509 ;
DYNJ67356, Lot Number 23GMC392 ;
DYNJ67356, Lot Number 23GMF016 ;
DYNJ67356, Lot Number 23IMC093 ;
DYNJ68141A , Lot Number 21GBP562 ;
DYNJ68141A , Lot Number 21GBP563 ;
DYNJ68141A , Lot Number 21HBE331 ;
DYNJ68141A , Lot Number 21HBE332 ;
DYNJ68141A , Lot Number 21HBE333 ;
DYNJ68141A , Lot Number 21LBV880 ;
DYNJ68141A , Lot Number 22BBL489 ;
DYNJ68141A , Lot Number 22CBZ936 ;
DYNJ68141A , Lot Number 22JBB075 ;
DYNJ68141A , Lot Number 22KBH325 ;
DYNJ68141A , Lot Number 22KBH328 ;
DYNJ68141A , Lot Number 22LBG746 ;
DYNJ68141A , Lot Number 22LBH297 ;
DYNJ68141A , Lot Number 21FBE538 ;
DYNJ81973, Lot Number 22IBP117 ;
DYNJ81973, Lot Number 22KBD374 ;
DYNJ900282I, Lot Number 21KBP591 ;
DYNJ900282I, Lot Number 21KBT464 ;
DYNJ900282I, Lot Number 22ABB461 ;
DYNJ900282I, Lot Number 22ABB463 ;
DYNJ900282I, Lot Number 19JBM899 ;
DYNJ900282I, Lot Number 20ABQ670 ;
DYNJ900282I, Lot Number 20CBP684 ;
DYNJ900282I, Lot Number 20FBD770 ;
DYNJ900282I, Lot Number 20HBB232 ;
DYNJ900282I, Lot Number 20IBS371 ;
DYNJ900282I, Lot Number 21ABO342 ;
DYNJ901706J, Lot Number 21VBA286 ;
DYNJ902831D, Lot Number 21FBJ190 ;
DYNJ902831D, Lot Number 21IBM004 ;
DYNJ902831D, Lot Number 21LBD683 ;
DYNJ902831D, Lot Number 22BBZ713 ;
DYNJ902831D, Lot Number 22BBZ714 ;
DYNJ902831D, Lot Number 22FBV579 ;
DYNJ902831D, Lot Number 22JBP701 ;
DYNJ902831D, Lot Number 22LBE910 ;
DYNJ902831D, Lot Number 23ABE854 ;
DYNJ902831D, Lot Number 23CBU007 ;
DYNJ902831D, Lot Number 23EBS895 ;
DYNJ902831D, Lot Number 20BBQ499 ;
DYNJ902831D, Lot Number 20DBL078 ;
DYNJ902831D, Lot Number 23HBS245 ;
DYNJ902831D, Lot Number 23HBV721 ;
DYNJ902831D, Lot Number 20GBQ825 ;
DYNJ902831D, Lot Number 21ABM136 ;
DYNJ902831D, Lot Number 21CBI323 ;
DYNJ902831D, Lot Number 21DBA613 ;
DYNJ902831D, Lot Number 21EBE932 ;
DYNJ903026I, Lot Number 21HBG045 ;
DYNJ903026I, Lot Number 21JBF899 ;
DYNJ903026I, Lot Number 21LBQ887 ;
DYNJ903026I, Lot Number 21LBT101 ;
DYNJ903026I, Lot Number 22ABL262 ;
DYNJ903026I, Lot Number 22CBQ782 ;
DYNJ903026I, Lot Number 22EBH394 ;
DYNJ903026I, Lot Number 22FBN286 ;
DYNJ903026I, Lot Number 22FBO294 ;
DYNJ903026I, Lot Number 22HBD275 ;
DYNJ903026I, Lot Number 22JBD736 ;
DYNJ903026I, Lot Number 22KBR557 ;
DYNJ903026I, Lot Number 22LBF810 ;
DYNJ903026I, Lot Number 22LBP894 ;
DYNJ903026I, Lot Number 23BBU279 ;
DYNJ903026I, Lot Number 23DBE331 ;
DYNJ903026I, Lot Number 20XBH077 ;
DYNJ903026I, Lot Number 21CBK392 ;
DYNJ903026I, Lot Number 21DBT674 ;
DYNJ903026I, Lot Number 21EBO665 ;
DYNJ906465 , Lot Number 21GBB817 ;
DYNJ906465 , Lot Number 21HBC384 ;
DYNJ906465 , Lot Number 21IBE980 ;
DYNJ906465 , Lot Number 21IBT610 ;
DYNJ906465 , Lot Number 21JBQ899 ;
DYNJ906465 , Lot Number 21LBT008 ;
DYNJ906465 , Lot Number 22OBB059 ;
DYNJ906465 , Lot Number 22DBK842 ;
DYNJ906465 , Lot Number 22HBS755 ;
DYNJ906465 , Lot Number 19JBB649 ;
DYNJ906465 , Lot Number 23DBB063 ;
DYNJ906465 , Lot Number 20ABJ976 ;
DYNJ906465 , Lot Number 23EBG910 ;
DYNJ906465 , Lot Number 23FBC277 ;
DYNJ906465 , Lot Number 20BBW586 ;
DYNJ906465 , Lot Number 23GBD648 ;
DYNJ906465 , Lot Number 23GBD885 ;
DYNJ906465 , Lot Number 20CBY319 ;
DYNJ906465 , Lot Number 23HBC365 ;
DYNJ906465 , Lot Number 20EBI678 ;
DYNJ906465 , Lot Number 23IBI567 ;
DYNJ906465 , Lot Number 20FBF086 ;
DYNJ906465 , Lot Number 20GBF057 ;
DYNJ906465 , Lot Number 23KBP623 ;
DYNJ906465 , Lot Number 23LBS829 ;
DYNJ906465 , Lot Number 24BBM457 ;
DYNJ906465 , Lot Number 21EBO736 ;
DYNJ906630 , Lot Number 21GBJ251 ;
DYNJ906630 , Lot Number 21IBU411 ;
DYNJ906630 , Lot Number 21KBF463 ;
DYNJ906630 , Lot Number 22OBI162 ;
DYNJ906630 , Lot Number 22EBE987 ;
DYNJ906630 , Lot Number 22FBM378 ;
DYNJ906630 , Lot Number 19VBE346 ;
DYNJ906630 , Lot Number 20BBW825 ;
DYNJ906630 , Lot Number 20DBD823 ;
DYNJ906630 , Lot Number 20FBD332 ;
DYNJ906630 , Lot Number 20JBD152 ;
DYNJ906630 , Lot Number 20KBK300 ;
DYNJ906630 , Lot Number 20LBM073 ;
DYNJ906630 , Lot Number 21DBU812 ;
LZ7759N, Lot Number 21GBJ635 ;
LZ7759N, Lot Number 21HBM661 ;
LZ7759N, Lot Number 21JBO860 ;
LZ7759N, Lot Number 21KBE902 ;
LZ7759N, Lot Number 21LBY679 ;
LZ7759N, Lot Number 22EBN393 ;
LZ7759N, Lot Number 22FBV159 ;
LZ7759N, Lot Number 22GBI846 ;
LZ7759N, Lot Number 19SBF783 ;
LZ7759N, Lot Number 22JBE759 ;
LZ7759N, Lot Number 19IBF315 ;
LZ7759N, Lot Number 22KBJ579 ;
LZ7759N, Lot Number 23BBK564 ;
LZ7759N, Lot Number 20ABB640 ;
LZ7759N, Lot Number 23DBJ306 ;
LZ7759N, Lot Number 23EBE090 ;
LZ7759N, Lot Number 20BBM517 ;
LZ7759N, Lot Number 23FBO318 ;
LZ7759N, Lot Number 20CBQ166 ;
LZ7759N, Lot Number 23GBN563 ;
LZ7759N, Lot Number 23HBO210 ;
LZ7759N, Lot Number 20FBN565 ;
LZ7759N, Lot Number 23JBR653 ;
LZ7759N, Lot Number 20GBB329 ;
LZ7759N, Lot Number 20HBG252 ;
LZ7759N, Lot Number 20LBO390 ;
LZ7759N, Lot Number 21ABE630 ;
LZ7759N, Lot Number 21CBJ886 ;
LZ7759N, Lot Number 21DBC026 ;
LZ7759N, Lot Number 21DBW425 ;
LZ7759N, Lot Number 21EBS653 ;
UVT1175, Lot Number 21LBI285 ;
UVT1175, Lot Number 22ABX753 ;
UVT1175, Lot Number 22CBJ600 ;
UVT1175, Lot Number 23GMC946 ;
UVT1175, Lot Number 23HMA547 ;
UVT1175, Lot Number 23HMC187 ;
UVT1175, Lot Number 23IMC220 ;
UVT1175, Lot Number 23JMF023 ;
UVT730, Lot Number 23DBO225;
UVT730, Lot Number 23BBJ969;
UVT730, Lot Number 23BBD067;
UVT730, Lot Number 22HBR771;
UVT730, Lot Number 22FBN134;
UVT730, Lot Number 22FBI749;
UVT730, Lot Number 22BBZ635;
UVT730, Lot Number 22ABB949;
UVT730, Lot Number 21KBC744;
UVT730, Lot Number 21IBT312;
UVT730, Lot Number 21GBK102;
UVT730, Lot Number 23DBO225;
UVT730, Lot Number 23BBJ969;
UVT730, Lot Number 23BBD067;
UVT730, Lot Number 22HBR771;
UVT730, Lot Number 22FBN134;
UVT730, Lot Number 22FBI749;
UVT730, Lot Number 22BBZ635;
UVT730, Lot Number 22ABB949;
UVT730, Lot Number 21KBC744;
UVT730, Lot Number 21IBT312;
UVT730, Lot Number 21GBK102;
TVS4000K, Lot Number 22FDB699
|
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 2 | 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.
|
|
|
|
