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U.S. Department of Health and Human Services

Class 1 Device Recall Medline

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  Class 1 Device Recall Medline see related information
Date Initiated by Firm November 15, 2023
Date Posted February 25, 2024
Recall Status1 Open3, Classified
Recall Number Z-1111-2024
Recall Event ID 93800
Product Classification General surgery tray - Product Code LRO
Product Medline Kits, trays, and packs labeled as follows:
a) 709E RECOVERY PACK A,B,C II SS, REF DYNJ55960G;
b) ABDOMEN PACK, REF DYNJ53643C;
c) BAG TRUNK STOCK KIT, REF DYKM1880;
d) BEDSIDE BRONCH PACK, REF DYKE1601;
e) BIOPSY TRAY, REF DYNDH1242;
f) BRONCH KIT, REF DYKE1840;
g) BRONCHOSCOPY PACK, REF DYNJ37775F;
h) BRONCHOSCOPY TRAY, REF DYNDL1350A;
i) BRONCHOSCOPY TRAY, REF DYNDL1350AH;
j) CAP CHANGE LARGE KIT, REF DYNDA2277A;
k) CAP CHANGE LARGE KIT, REF DYNDA2277B;
l) DAILY VAD DRIVELINE KIT, REF DYNDC3006;
m) DAILY VENT KIT, REF DYNDJ1076;
n) DIALYSIS OFF KIT, REF DT21230A;
o) DIALYSIS OFF KIT, REF DT20350B;
p) DIALYSIS ON KIT, REF DT20355B;
q) DOUBLE HUB/CAP CHANGE KIT, REF DYNDC2843;
r) DR D CUSTOM PACK, REF DYNJ68068A;
s) DR D CUSTOM PACK, REF DYNJ68068B;
t) DUODENUM CULTURING PACK, REF DYNJ51294;
u) EGD SOUTHEASTERN REG KIT, REF DYKE1830;
v) EMERGENCY UMBILICAL INSERTION, REF UVT1165;
w) ENDO KIT, REF DYKE1069B;
x) ENDO KIT, REF DYKE1475B;
y) ERCP ENDO KIT, REF P604360B;
z) ERCP SOUTHEASTERN REG KIT, REF DYKM2127;
aa) FACIAL PLASTY PACK, REF DYNJ55335D;
bb) FIRST YEAR KIT LF, REF EDUC1037;
cc) FOLEY BULB INDUCTION KIT, REF MNS13545;
dd) G BUNDLE CDS, REF CDS982759;
ee) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330B;
ff) GBMC ULTRASOUND GUIDED PIV KIT, REF DYNDV2330C;
gg) GENERAL/HERNIA PACK, REF DYNJ38541B;
hh) GI BRONCHOSCOPY KIT, REF DYKE1254C;
ii) HH CAR STOCK IN BIN, REF DYKM1883;
jj) IMMERSION 4, REF EDUC05059A;
kk) KIT LINE INSERTION, REF CVI4730;
ll) KIT, PEG, SOUTHEASTERN REG, REF DYKM2128;
mm) LINE INSERT PACK, REF PHS422216004C;
nn) MANUAL BLADDER IRRIGATION KIT, REF UROT1051;
oo) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051A;
pp) MANUAL BLADDER IRRIGATION KIT1, REF UROT1051AH;
qq) MOHS KIT, REF DYNDA2072A;
rr) MULTI LUMEN CAP CHANGE, REF DYNDA2390A;
ss) N HOME CARE WOUND KIT, REF DYK1188079W;
tt) NURSE KIT NO LOGO-LF, REF EDUC05036;
uu) NURSE TOTE, REF DYKM1872A;
vv) NURSING SKILLS, REF EDUC05015A;
ww) PICC, REF CDS980470D;
xx) PRE OP KIT, REF DYKS1262A;
yy) PULMONARY SETUP KIT, REF DYNDA2648;
zz) PULMONARY SETUP KIT, REF DYNDA2648H;
aaa) REDDY JOINT BATH, REF MMJB001;
bbb) REDDY JOINT BATH, REF MMJB001A;
ccc) RNSG 1441, REF EDUC1029;
ddd) RNSG 1441, REF EDUC1029H;
eee) RNSG 2201, REF EDUC1034;
fff) RNSG 2201, REF EDUC1034H;
ggg) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185;
hhh) SHEATH REMOVAL TRAY, REF DYNDC1311C;
iii) SHORT TERM KIT, REF DYNDC3092;
jjj) SINGLE HUB/CAP CHANGE KIT, REF DYNDC2841;
kkk) STERILE CAP CHANGE, REF DYNDA2387A;
lll) STERILE PREP KIT, REF DYNDA1359;
mmm) STERILE PREP KIT, REF DYNDA1359A;
nnn) STRL EK SINGLE PACK, REF DYNDA1360B;
ooo) SUB PORT ACCESS TRAY, REF DYNDC2768A;
ppp) SUPRA PUBIC IRRIGATION TRAY ST, REF DYNDT1019;
qqq) SURGICAL PREP KIT, REF DYNJ46340B;
rrr) SUTURE KIT, REF M101494;
sss) SUTURE TRAY, REF DYNDS1085A;
ttt) TRUNK KIT, REF DYKTRUNK1;
uuu) TRUNK KIT 1EA, REF DYKM2013;
vvv) UMBILICAL VESSEL INSERTION, REF DYNDA3011;
www) URINALYSIS KIT, REF DYKM1251;
xxx) VAD ACCESS CHANGE KIT, REF DYNDC2882B;
yyy) VAD DRESSING KIT A, REF DYNDA2164;
zzz) CENTRAL BLOOD CULTURE KIT, REF DYNDH1342B;
aaaa) CVC DRESSING CHANGE KIT, REF EBSI1552;
bbbb) PORT ACCESS POWER LOC KIT, REF DYNDC1712B;
cccc) PORT ACCESS TRAY, REF DYNDC1128B;

Code Information a) REF DYNJ55960G, UDI/DI 40193489917827 (case), 10193489917826 (unit), Lot Numbers: 23ALA126; b) REF DYNJ53643C, UDI/DI 40889942615354 (case), 10889942615353 (unit), Lot Numbers: 22CLA226, 22ELA033, 22GLA633, 22JLA774, 23BLA613, 23ELA554, 23FLA005; c) REF DYKM1880, UDI/DI 40193489807524 (case), 10193489807523 (unit), Lot Numbers: 22FLA285, 23FLA657, 23HLA920; d) REF DYKE1601, UDI/DI 40889942956082 (case), 10889942956081 (unit), Lot Numbers: 23ABG889, 23BBN595, 23BBU202, 23FBA860, 23HBI592; e) REF DYNDH1242, UDI/DI 40889942598138 (case), 10889942598137 (unit), Lot Numbers: 22GLA574, 22KLA372, 22LLA696, 23ALA194, 23BLA985, 23CLA356, 23ELA844, 23FLA654, 23GLB027, 23HLA029, 23ILA700, 23JLB281; f) REF DYKE1840, UDI/DI 40195327105649 (case), 10195327105648 (unit), Lot Numbers: 22BBT072, 22EBU502, 22KBM213, 22LBH747; g) REF DYNJ37775F, UDI/DI 40888277906182 (case), 10888277906181 (unit), Lot Numbers: 22FDB681, 23ADC041, 23HDA605; h) REF DYNDL1350A, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers: 22GBH314, 23ABI645, 23BBL282, 23BBU137, 23EBM149, 23FBC531, 23GBJ019, 23HBD916; i) REF DYNDL1350AH, UDI/DI 40889942880486 (case), 10889942880485 (unit), Lot Numbers: 22GBH314, 23ABI645, 23BBL282, 23BBU137, 23EBM149, 23FBC531, 23GBJ019, 23HBD916; j) REF DYNDA2277A, UDI/DI 40195327004423 (case), 10195327003944 (unit), Lot Numbers: 21LBS528, 22ABD844, 22BBE910; k) REF DYNDA2277B, UDI/DI UDI/DI 40195327120796 (case), 10195327120795 (unit), Lot Numbers: 22CBP893, 22DBQ630, 22IBG117; l) REF DYNDC3006, UDI/DI 40193489421256 (case), 10193489421255 (unit), Lot Numbers: 22EBO159; m) REF DYNDJ1076, UDI/DI 40889942790617 (Case), 10889942790616 (unit), Lot Numbers: 22IBS404, 23BBU808, 23FBQ938; n) REF DT21230A, UDI/DI 40653160991503 (case), 10653160991502 (unit), Lot Numbers: 21LBS504, 22ABZ147, 22CBX302, 22DBD319, 22HBU059, 22IBG323; o) REF DT20350B, UDI/DI 40653160991558 (case), 10653160991557 (unit), Lot Numbers; : 21LBT644, 22ABJ769, 22ABN465, 22ABU739, 22DBE295, 22GBD122, 22IBG207; p) REF DT20355B, UDI/DI 40653160991541 (case), 10653160991540 (unit), Lot Numbers: 22BBR313, 22DBG177, 22IBB820, 22IBG220; q) REF DYNDC2843, UDI/DI 40193489342575 (case), 10193489342574 (unit), Lot Numbers: 22ABB003, 22CBZ660, 22GBA430; r) REF DYNJ68068A, UDI/DI 40193489880190 (case), 10193489880199 (unit), Lot Numbers: 21LBS172, 21LBS192, 22DBE425, 22IBS035, 22KBR704, 22OBD030, 22OBD031; s) REF DYNJ68068B, UDI/DI 40195327306503 (case), 10195327306502 (unit), Lot Numbers: 23ABR366, 23CBT225, 23DBF157, 23HBI634, 23IBB018; t) REF DYNJ51294, UDI/DI 40889942148098 (case), 10889942148097 (unit), Lot Numbers: 22ABA731, 22ABU356, 22EBQ983, 23EBL823; u) REF DYKE1830, UDI/DI 40195327044207 (case), 10195327044206 (unit), Lot Numbers: 22BLA237, 22BLA491, 22DLA830, 22FLA559, 22GLA591, 22ILA148, 23DLA944, 23ELB067, 23FLA478; v) REF UVT1165, UDI/DI 40653160992319 (case), 10653160992318 (unit), Lot Numbers: 22EBE234, 22EBI596, 22OBD981; w) REF DYKE1069B, UDI/DI 40889942907169 (case), 10889942907168 (unit), Lot Numbers: 21LBJ553, 22ABO501, 23FBA549; x) REF DYKE1475B, UDI/DI 40889942893721 (case), 10889942893720 (unit), Lot Numbers: 22HDA831 y) REF P604360B, UDI/DI 10653160166382 (case), 00653160166385 (unit), Lot Numbers: 22KLA323, 22LLA144, 23ELB061; z) REF DYKM2127, UDI/DI 40195327045013 (case), 10195327045012 (unit), Lot Numbers: 22FLA082; aa) REF DYNJ55335D, UDI/DI 40889942703228 (case), 10889942703227 (unit), Lot Numbers: 22EBM568, 22EBV274, 22LBP469, 23CBV507, 23DBT035, 23GBU056, 23JBR179; bb) REF EDUC1037, UDI/DI 40195327372331 (case), 10195327372330 (unit), Lot Numbers: 23DDA939, 23EDA052, 23EDB633; cc) REF MNS13545, UDI/DI 40653160991886 (case), 10653160991885 (unit), Lot Numbers: 21LBS695, 22CBE432, 22CBO137, 22OBC049; dd) REF CDS982759, UDI/DI 40884389451039 (case), 10884389451038 (unit), Lot Numbers: 22HBS221, 22KBB842, 22KBM294, 23DBL304, 23JBR357; ee) REF DYNDV2330B, UDI/DI 40195327001323 (case), 10195327001322 (unit), Lot Numbers: 21LBT031, 22OBL922; ff) REF DYNDV2330C, UDI/DI 40195327001323 (case), 10195327001322 (unit), Lot Numbers: 22OBL927; gg) REF DYNJ38541B, UDI/DI 40888277543974 (case), 10888277543973 (unit), Lot Numbers: 22FLA088, 22GLA360, 23CLA092, 23ELA016, 23FLA996; hh) REF DYKE1254C, UDI/DI 40889942782582 (case), 10889942782581 (unit), Lot Numbers: 22EDB717 ii) REF DYKM1883, UDI/DI 40193489234207 (case), 10193489234206 (unit), Lot Numbers: 22FBM572, 22FBR108, 22FBW122, 22HBF886; jj) REF EDUC05059A, UDI/DI 40195327203888 (case), 10195327203887 (unit), Lot Numbers: 23DLA805, 23ELA502, 23ELA556, 23ELB066, 23ELB153; kk) REF CVI4730, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22ABA994; ll) REF DYKM2128, UDI/DI 40195327045037 (case), 10195327045036 (unit), Lot Numbers: 22BLA697, 22CLA586. 22GLA027; mm) REF PHS422216004C, UDI/DI 10653160193081 (case), 00653160193084 (unit), Lot Numbers: 22OBG190, 22OBH215, 23EBS025, 23GBA226; nn) REF UROT1051, UDI/DI 40888277791764 (case), 10888277791763 (unit), Lot Numbers: 22BBA990, 22CBC606, 22DBQ612; oo) REF UROT1051A, UDI/DI40195327265992 (case), 10195327265991 (unit), Lot Numbers: 22JBS891, 22LBQ270, 22LBT353, 23JBO274, 23JBR988; pp) REF UROT1051AH, UDI/DI 40195327265992 (case), 10195327265991 (unit), Lot Numbers: 22JBS891, 22LBQ270, 22LBT353, 23JBO274, 23JBR988; qq) REF DYNDA2072A, UDI/DI 40193489586894 (case), 10193489586893 (unit). Lot Numbers: 22EBB022, 22FBN102, 22HBB085, 22KBG396, 22KBV529, 22LBJ527, 23EBC809, 23HBW281, 23IBR346; rr) REF DYNDA2390A, UDI/DI 40195327025671 (case), 10195327025670 (unit), Lot Numbers: 22MBA027; ss) REF DYK1188079W, UDI/DI 40080196854401 (case), 10080196854400 (unit), Lot Numbers: 22FBB386, 22HBU679, 22IBS684, 22LBD220, 23EBE385, 23FBJ776; tt) REF EDUC05036, UDI/DI 40193489846370 (case), 10193489846379 (unit), Lot Numbers: 22FLA555, 22KLA681, 23BLA125, 23BLA486, 23CLA375, 23CLA977, 23CLB254, 23DLA481, 23ELA396, 23FLA274, 23GLA325, 23HLA852, 23HLA997, 23JLA948, 23JLA949; uu) REF DYKM1872A, UDI/DI 40193489905404 (case), 10193489905403 (unit), Lot Numbers: 22IBV070, 22KBB323, 22KBE868, 23BBA791; vv) REF EDUC05015A, UDI/DI 40193489849036 (case), 10193489849035 (unit), Lot Numbers: 22FDB801, 22KDA995, 23FDB243; ww) REF CDS980470D, UDI/DI 40889942965046 (case), 10889942965045 (unit), Lot Numbers: 22IBU333; xx) REF DYKS1262A, UDI/DI 40193489481854 (case), 10193489481853 (unit), Lot Numbers: 22DMG419, 22EMH939, 22LMF533; yy) REF DYNDA2648, UDI/DI 40195327139972 (case), 10195327139971 (unit), Lot Numbers: 22GBO511, 22IBH087, 22JBI924; zz) REF DYNDA2648H, UDI/DI 40195327139972 (case), 10195327139971 (unit), Lot Numbers: 22GBO511, 22IBH087, 22JBI924; aaa) REF MMJB001, UDI/DI 40888277780553 (case), 10888277780552 (unit), Lot Numbers: 22DBO120, 22GBT358, 22JBV937, 22KBU083, 23ABL640, 23BBP851, 23DBD413; bbb) REF MMJB001A, UDI/DI 40195327514878 (case), 10195327514877 (unit), Lot Numbers: 23JBD137; ccc) REF EDUC1029, UDI/DI 40195327318520 (case), 10195327318529 (unit), Lot Numbers: 23CLA441, 23DLB129; ddd) REF EDUC1029H, UDI/DI 40195327318520 (case), 10195327318529 (unit), Lot Numbers: 23CLA441, 23DLB129; eee) REF EDUC1034, UDI/DI 40195327318940 (case) 10195327318949 (unit), Lot Numbers: 23CLA376; fff) REF EDUC1034H, UDI/DI 40195327318940 (case), 10195327318949 (unit), Lot Numbers: 23CLA376; ggg) REF DYNDC3185, UDI/DI 40195327034109 (case), 10195327034108 (unit), Lot Numbers: 23BBK719, 23CBM278, 23DBF310, 23DBN505, 23EBC880, 23EBU809; hhh) REF DYNDC1311C, UDI/DI 40080196151562 (case), 10080196151561 (unit), Lot Numbers: 22EBB019, 22IBB934, 23CBN984; iii) REF DYNDC3092, UDI/DI 40193489878500 (case), 10193489878509 (unit), Lot Numbers: 22ABZ049, 22HBS850, 22IBG383; jjj) REF DYNDC2841, UDI/DI 40193489364676 (case), 10193489364675 (unit), Lot Numbers: 22ABB008, 22CBX108, 22CBY133, 22CBZ300, 22DBP299, 22IBA926, 22IBG249; kkk) REF DYNDA2387A, UDI/DI 40195327025077 (case), 10195327025076 (unit), Lot Numbers: 22BBW633, 22DBD284, 22HBH277, 22IBI878; lll) REF DYNDA1359, UDI/DI 40195327417735 (case), 10195327417734 (unit), Lot Numbers: 22GBI645, 22IBP085, 22KBH590, 22KBV524; mmm) REF DYNDA1359A, UDI/DI 40195327417735 (case), 10195327417734 (unit), Lot Numbers: 23FBK812, 23FBP270, 23HBV043, 23IBN603; nnn) REF DYNDA1360B, UDI/DI 40889942903864 (case), 10889942903863 (unit), Lot Numbers: 22EBN763, 22KBN275, 23BBF919, 23EBR548, 23HBM494; ooo) REF DYNDC2768A, UDI/DI 40195327008025 (case), 10195327008024 (unit), Lot Numbers: 22ABJ771, 22DBB123; ppp) REF DYNDT1019, UDI/DI 40080196954316 (case), 10080196954315 (unit), Lot Numbers: 22EBB037, 22GLA426, 22GLA485, 22HLA020, 22HLA318, 22HLA933; qqq) REF DYNJ46340B, UDI/DI 40193489267502 (case), 10193489267501 (unit), Lot Numbers: 22EBG807, 22JBI745, 22KBO369, 23BBC803, 23DBD059, 23GBT971, 23HBK037; rrr) REF M101494, UDI/DI 40193489215268 (case), 10193489215267 (unit), Lot Numbers: 22EBB001, 22FBW213, 22GBA533, 22IBH767, 22JBR552, 23ABH794, 23ABO157, 23BBD517, 23CBT240, 23DBS004, 23FBF076, 23GBW208; sss) REF DYNDS1085A, UDI/DI 40080196778692 (case), 10080196778690 (unit), Lot Numbers: 22GBD145, 22GBT473, 22HBW597, 22JBQ784, 22LBK199, 23DBF574, 23EBB065, 23FBI285; ttt) REF DYKTRUNK1, UDI/DI 40888277572196 (case), 10888277572195 (unit), Lot Numbers: 22IBB692, 22IBT561, 22KBN272, 22KBN273; uuu) REF DYKM2013, UDI/DI 40193489796583 (case), 10193489796582 (unit), Lot Numbers: 23ABB515, 23CBM980; vvv) REF DYNDA3011, UDI/DI 40195327283231 (case), 10195327283230 (unit), Lot Numbers: 23ABV484, 23BBS928, 23CBF143, 23CBP415; www) REF DYKM1251, UDI/DI 40889942146445 (case), 10889942146444 (unit), Lot Numbers: 22MBA574, 23JBO199; xxx) REF DYNDC2882B, UDI/DI 40193489417105 (case), 10193489417104 (unit), Lot Numbers: 22CBS826, 22IBG358, 22MBA772; yyy) REF DYNDA2164, UDI/DI 40889942789642 (case), 10889942789641 (unit), Lot Numbers: 22ABG432, 22ABU607, 22DBG204, 22IBG168, 22JBG542, 23ABC729, 23BBN712, 23CBM329, 23EBU380; zzz) REF DYNDH1342B, UDI/DI 20193489111900 (case), 10193489111903 (unit), Lot Numbers: 2022042580; aaaa) REF EBSI1552, UDI/DI 00653160352320 (case), 10653160352327 (unit), Lot Numbers: 2022061380; bbbb) REF DYNDC1712B, UDI/DI 40888277279415 (case), 10888277279414 (unit), Lot Numbers: 2022032180; cccc) REF DYNDC1128B, UDI/DI 40888277950802 (case), 10888277950801 (unit), Lot Numbers: 2022032850, 2022050450
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		 Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action MEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce 26171 units
Distribution Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
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.
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