Z-1117-2024 Class I Ongoing

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

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.

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