Class I FDA device recall · Z-1117-2024

Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone.

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

Why it was recalled

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / 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

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-1117-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Northfield, IL
Recall initiated: 2023-11-15

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-1117-2024 · Source: openFDA enforcement.