Medline Kits, trays, and packs labeled as follows: a) CENTRAL LINE TRAY
Medical device recall Z-1117-2024. Published in FDA’s Enforcement Report on Mar 6, 2024.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 6, 2024. Copied from openFDA on Oct 24, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 86699 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Which ones are recalled?
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
86699 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,986 characters
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…
FDA’s list runs to 5,988 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Nov 15, 2023.
- FDA classified it on Feb 24, 2024.
- FDA’s Enforcement Report published it on Mar 6, 2024.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
Who is recalling it?
- MEDLINE INDUSTRIES, LP - Northfield, of Northfield, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 23, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 5,988 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 23, 2026 and checked Oct 23, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 24, 2026.