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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-1117-2024
Recall Event ID 93800
Product Classification Dressing change tray - Product Code OXQ
Product Medline Kits, trays, and packs labeled as follows:
a) CENTRAL LINE TRAY, REF CVI4705;
b) DAILY DRIVELINE MGMT KIT w/PER, REF DT18700;
c) DRESSING CHANGE TRAY, REF DYNDC3131A;
d) DRIVELINE MAINTENANCE PACKAGE, REF DT17405A;
e) DRSG CHANGE TRAY W/ CHG, REF DT21460B;
f) DRSG CHANGE TRAY W/ CHG, REF DT21460BH;
g) LVAD MANAGEMENT SYSTEM - ACUTE, REF DM580;
h) LVAD MANAGEMENT SYSTEM - ACUTE, REF DM580H;
i) PEDIATRIC PORT KIT W/ DRESSING, REF DYNDC3120A;
j) PORT ACCESS DRSG KIT W OUT CHG, REF DYNDC3081;
k) PORT ACCESS DRSG KIT WITH CHG, REF DYNDC3080;
l) PORT ACCESS PACK-LF, REF DYNJ0352159D;
m) PORT DRESSING CHANGE KIT, REF DT22810;
n) PORT DRESSING CHANGE TRAY, REF DT20640B;
o) PORT DRESSING CHANGE TRAY, REF DYNDC3052A;
p) PORT DRESSING CHANGE TRAY, REF DYNDC3052AH;
q) POST OP,20-DAY SUPPLY 40/CS, REF DYKM1528;
r) POST OP,20-DAY SUPPLY 40/CS, REF DYKM1528H;
s) SALINE GAUZE DRESSING TRAY, REF DYNDA2937;
t) SALINE GAUZE DRESSING TRAY, REF DYNDA2937A;
u) SALINE GAUZE DRESSING TRAY, REF DYNDA2937AH;
v) ADULT MEDIPORT DRESSING KIT, REF DYNDC3161;
w) A-LINE/PORT DRESSING CHANGE KIT, REF EBSI1530;
x) CENTRAL LINE DRESSING CHANGE KIT, REF EBSI1489;
y) CENTRAL LINE DRESSING KIT, REF EBSI1088A;
z) CENTRAL LINE DRESSING KIT, REF EBSI1088B;
aa) CENTRAL LINE KIT, REF EBSI1245B;
bb) CENTRAL LINE/PICC DRESSING CHANGE SYSTEM, REF DYNDC2925B;
cc) CVC DRESSING CHANGE KIT, REF EBSI1472A;
dd) CVC/PICC DRESSING CHANGE KIT, REF EBSI1110C;
ee) CVL DRESSING CHANGE KIT, REF EBSI1547;
ff) DIALYSIS CHANGE KIT, REF EBSI1453;
gg) DIALYSIS KIT, REF EBSI1476;
hh) DRESSING CHANGE KIT WITH CHLORAPREP, REF EBSI1413A;
ii) DRESSING CHANGE TRAY, REF EBSI1513;
jj) EBSI DRESSING CHANGE KIT, REF EBSI1163B;
kk) ERASE BSI CENTRAL LINE DRSNG CHNG KIT, REF EBSI1415A;
ll) ERASE BSI CVC DRSNG CHNGE KIT, REF EBSI1161A;
mm) IJ/Introducer/Dialysis Dressing Change K, REF EBSI1524;
nn) IJ/Introducer/Dialysis Dressing Change K, REF EBSI1524;
oo) LARGE BORE DRESSING CHANGE KIT, REF EBSI1555;
pp) OUTPATIENT INFUSION DRSG CHNG, REF DYNDC3135;
qq) OUTPATIENT PORT ACCESS TRAY, REF DT22500A;
rr) PACK CHEST PORT KIT INPATIENT, REF DYNDC3087;
ss) PICC DRESSING CHANGE KIT, REF EBSI1471A;
tt) PICC DRESSING CHANGE TRAY, REF EBSI1512;
uu) PICC DRESSING CHANGE TRAY, REF EBSI1546;
vv) PICC/CENTRAL LINE DRESSING CHANGE TRAY, REF EBSI1486;
ww) PICC/MIDLINE DRESSING CHANGE TRAY, REF EBSI1523;
xx) PORT ACCESS TRAY, REF DYNDC2703A;
yy) PORT DRESSING CHANGE KIT, REF EBSI1434A;
zz) PORT DRESSING CHANGE KIT, REF EBSI1525;
aaa) PORT DRESSING CHANGE KIT, REF EBSI1525;
bbb) PORT DRESSING CHANGE TRAY, REF EBSI1208A;
ccc) SMALL BORE DRESSING CHANGE KIT, REF EBSI1556
Code Information a) REF CVI4705, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23FMD562; b) REF DT18700, UDI/DI 653160275087 (case), 10653160275084 (unit), Lot Numbers; 23BBJ923, 23CBB549, 23FBM548, 23GBF094, 23GBR827, 23HBM237; c) REF DYNDC3131A, UDI/DI 40195327105694 (case), 10195327105693 (unit), Lot Numbers: 22CBJ619, 22DBD254, 22IBG214; d) DT17405A, UDI/DI 40653160991619 (case), 10653160991618 (unit), Lot Numbers: 22CBY954, 22DBB495, 22DBH244, 22HBT273; e) DT21460B, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041; f) DT21460BH, UDI/DI 40653160991572 (case), 10653160991571 (unit), Lot Numbers: 22ABZ051, 22OBC041; g) DM580, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300; h) DM580H, UDI/DI 653160286984 (case), 10653160286981 (unit), Lot Numbers: 22EBB241, 22FBE733, 22JBR597, 23ABL651, 23BBB038, 23CBU481, 23FBD719, 23GBN340, 23IBE764, 23IBT300; i) DYNDC3120A, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME583, 23FMC905; j) DYNDC3081, UDI/DI 40193489849746 (case), 10193489849745 (unit), Lot Numbers: 22CBG508; k) DYNDC3080, UDI/DI 40193489849739 (case), 10193489849738 (unit), Lot Numbers: 22BBR416, 2EBD704; l) DYNJ0352159D, UDI/DI 40195327056125 (case), 10195327056124 (unit), Lot Numbers: 23AME774; m) DT22810, UDI/DI 40653160993361 (case), 10653160993360 (unit), Lot Numbers: 22IBI823; n) DT20640B, UDI/DI 40653160991671 (case), 10653160991670 (unit), Lot Numbers: 22ABT093, 22JBB214; o) DYNDC3052A, UDI/DI 40195327160129 (case), 10195327160128 (unit), Lot Numbers: 22LMI145; p) DYNDC3052AH, UDI/DI 40195327160129 (case), 10195327160128 (unit), Lot Numbers:22LMI145; q) DYKM1528, UDI/DI 40889942689928 (case), 10889942689927 (unit), Lot Numbers: 22HBZ240, 22KBR167; r) DYKM1528H, UDI/DI 40889942689928 (case), 10889942689927 (unit), Lot Numbers: 22HBZ240, 22KBR167; s) DYNDA2937, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers: 22JBK727, 22JBT535, 23CBX574; t) DYNDA2937A, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers:23DBF619, 23EBK506, 23FBF438, 23HBN471, 23IBN607; u) DYNDA2937AH, UDI/DI 40195327132379 (case), 10195327132378 (unit), Lot Numbers: 23EBK506, 23FBF438, 23HBN471, 23IBN607 v) REF DYNDC3161, UDI/DI 20193489111627 (case), 10193489111620 (unit), Lot Numbers: 2022031480, 2022061380, 2022082980; w) REF EBSI1530, UDI/DI 00653160354195 (case), 10653160354192 (unit), Lot Numbers: 2022082280; x) REF EBSI1489, UDI/DI 20193489111238 (case), 10193489111231 (unit), Lot Numbers: 2022011350, 2022022880, 2022082280; y) REF EBSI1088A, UDI/DI 20193489111726 (case), 10193489111729 (unit), Lot Numbers: 2022022180; z) REF EBSI1088B, UDI/DI 00653160352689 (case), 10653160352686 (unit), Lot Numbers: 2022061380, 2022082280; aa) REF EBSI1245B, UDI/DI 20193489110828 (case), 10193489110821 (unit), Lot Numbers: 2022031480, 2022082280; bb) REF DYNDC2925B, UDI/DI 00653160349832 (case), 10653160349839 (unit), Lot Numbers: 2022012450, 2022021050, 2022022180; cc) REF EBSI1472A, UDI/DI 20193489112594 (case), 10193489112597 (unit), Lot Numbers: 2021122950, 2022021480; dd) REF EBSI1110C, UDI/DI 00653160352269 (case), 10653160352266 (unit), Lot Numbers: 2022052380; ee) REF EBSI1547, UDI/DI 00653160352276 (case), 10653160352273 (unit), Lot Numbers: 2022050980; ff) REF EBSI1453, UDI/DI 20193489110194 (case), 10193489110197 (unit), Lot Numbers: 2022022180, 2022032880; gg) REF EBSI1476, UDI/DI 20193489110156 (case), 10193489110159 (unit), Lot Numbers: 2022012480, 2022082280; hh) REF EBSI1413A, UDI/DI 20193489112198 (case), 10193489112191 (unit), Lot Numbers: 2022031480; ii) REF EBSI1513, UDI/DI 20193489112617 (case), 10193489112610 (unit), Lot Numbers: 2021122950, 2022012480; jj) REF EBSI1163B, UDI/DI 20193489112112 (case), 10193489112115 (unit), Lot Numbers: 2022050980, 2022061380; kk) REF EBSI1415A, UDI/DI 20193489112235 (case), 10193489112238 (unit), Lot Numbers: 2022021650; ll) REF EBSI1161A, UDI/DI 20193489111801 (case), 10193489111804 (unit), Lot Numbers: 2022012480, 2022022880, 2022082280; mm) REF EBSI1524, UDI/DI 00653160349238 (case), 10653160349235 (unit), Lot Numbers: 2021122950, 2022082280; nn) REF EBSI1524, UDI/DI 00653160350784 (case), 10653160350781 (unit), Lot Numbers: 2021122950, 2022082280; oo) REF EBSI1555, UDI/DI 00653160354508 (case), 10653160354505 (unit), Lot Numbers: 2022082280; pp) REF DYNDC3135, UDI/DI 20193489111221 (case), 10193489111224 (unit), Lot Numbers: 2022032180, 2022040480, 2022061380, 2022062080, 2022082280; qq) REF DT22500A, UDI/DI 00653160349795 (case), 10653160349792 (unit), Lot Numbers: 2022020850, 2022050950, 2022061380; rr) REF DYNDC3087, UDI/DI 20193489110477 (case), 10193489110470 (unit), Lot Numbers: 2022013180, 2022020180, 2022020280; ss) REF EBSI1471A, UDI/DI 20193489112600 (case), 10193489112603 (unit), Lot Numbers: 2021121750, 2022020780; tt) REF EBSI1512, UDI/DI 20193489112624 (case), 10193489112627 (unit), Lot Numbers: 2022013180; uu) REF EBSI1546, UDI/DI 00653160352283 (case), 10653160352280 (unit), Lot Numbers: 2022050280; vv) REF EBSI1486, UDI/DI 20193489111184 (case), 10193489111187 (unit), Lot Numbers: 2022041880, 022082280; ww) REF EBSI1523, UDI/DI 00653160349191 (case), 10653160349198 (unit), Lot Numbers: 2021122950, 2022040480; xx) REF DYNDC2703A, UDI/DI 00653160348675 (case), 10653160348672 (unit), Lot Numbers: 2022012480, 2022061380; yy) REF EBSI1434A, UDI/DI 00653160348620 (case), 10653160348627 (unit), Lot Numbers: 2021122150, 2022012480, 2022061380; zz) REF EBSI1525, UDI/DI 00653160349214 (case), 10653160349211 (unit), Lot Numbers: 2021122950; aaa) REF EBSI1525, UDI/DI 00653160350791 (case), 10653160350798 (unit), Lot Numbers: 2021122950; bbb) REF EBSI1208A, UDI/DI 00653160349047 (case), 10653160349044 (unit), Lot Numbers: 2022021480, 2022082280; ccc) REF EBSI1556, UDI/DI 00653160354492 (case), 10653160354499 (unit), Lot Numbers: 2022082280
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 86699 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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