Class I FDA device recall · Z-1097-2024

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) ARTERIAL LINE PACK, REF DYNJ65208A; b) CANCER SERVICE PORT KIT, REF DT22710; c) CAP CHANGE KIT, REF DYNDC2002A; d) CAP CHANGE KIT, REF DYNDC2723A; e) CAP CHANGE KIT, REF DYNDC2723B; f) CENTRAL LINE INSERTION PACK, REF CVI4805; g) CENTRAL LINE TRAY, REF CVI4705; h) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721A; i) CNTRL LINE DRSG CHG OUTPATIENT, REF DYNDC2721B; j) CVC INSERTION PACK, REF CVI4720; k) CVC INSERTION PACK, REF CVI4720A; l) CVC INSERTION PACK, REF CVI4720AH; m) DERM SURG CUSTOM PACK, REF DYNDA1584C; n) ER CENTRAL LINE KIT, REF P155508D; o) FISTULA GRAFT KIT, REF DT20345A; p) IMPLANTED PORT ACCESS, REF DYNDC2765B; q) IVAD KIT, REF DYNDC2004B; r) KIT LINE INSERTION, REF CVI4730H; s) KIT LINE INSERTION, REF CVI4730; t) LINE CHANGE KIT, REF DYNDC2927A; u) MAX BARRIER PACK, REF DYNJ50717; v) MEDIPORT W/CHG, REF DYNDC2219B; w) MEDIPORT W/CHG, REF DYNDC2219BH; x) NICU PICC INSERTION KIT, REF CVI4395B; y) PACK,CENTRAL LINE, REF DYNJ906907B; z) PEDI CENTRAL LINE AND PORT ACC, REF DT19740A; aa) PEDS INFANT LUMBAR PUNCTURE, REF DYNDH1636; bb) PEDS/ NICU LINE KIT, REF MNS13555; cc) PICC LINE PACK, REF DYNJ64249A; dd) PICC LINE TRAY, REF DYNDC2170; ee) PORT ACCESS KIT, REF DYNDC3251; ff) PORT ACCESS KIT, REF DYNDC3251H; gg) PORT ACCESS KIT, REF DYNDC3252; hh) PORT ACCESS SUPPLIES, REF DYNDA2142B; ii) PORT ACCESS TRAY, REF DYNDC2449B; jj) PORT ACCESS TRAY, REF DYNDC3066; kk) PORT ACCESS TRAY, REF DYNDC3103; ll) PORT ACCESS/LAB KIT, REF DYNDC3129A; mm) PORT ACCESS/LAB KIT, REF DYNDC3129AH; nn) PORT FULL ACCESS TRAY, REF DT19330B; oo) PORT KIT, REF DT22785; pp) PORT KIT W/ HUBER NEEDLE, REF DT22780; qq) PORT-A-CATH ACCESS KIT, REF DYNDC1994C; rr) PORT-A-CATH ACCESS KIT, REF DYNDC1994D; ss) PORT-A-CATH ACCESS KIT, REF DYNDC1994DH; tt) SUBCLAVIAN PORT ACCESS, REF DYNDC2555C; uu) USG PIV INSERTION KIT, REF DYNDV2480; vv) USG PIV INSERTION KIT, REF DYNDV2480H; ww) VAD DRESSING CHANGE TRAY, REF DYNDC2078; xx) VAD DRESSING CHANGE TRAY, REF DYNDC2078H; yy) VAD DRESSING CHANGE TRAY, REF DYNDC2657A; zz) VAD KIT WITHOUT VALVES, REF DYNDC3179; aaa) VEIN CLOSURE PACK, REF DYNJ69976

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 DYNJ65208A, UDI/DI 40195327120598 (case), 10195327120597 (unit), Lot Numbers:  23CMB532, 23CME753, 23EMD721, 23FMH948;   b) REF DT22710, UDI/DI 40653160990636 (case), 10653160990635 (unit), Lot Numbers:    c) REF DYNDC2002A, UDI/DI 21LBV542, 22CBM841, 22IBG132;   d) REF DYNDC2723A, UDI/DI 40193489999236 (case), 10193489999235 (unit), Lot Numbers:  22ABH235, 22BBF113, 22IBG479;   e) REF DYNDC2723B, UDI/DI 40195327007028 (case), 10195327004255 (unit), Lot Numbers:  22ABZ109, 22BBK108;   f) REF CVI4805, UDI/DI 40195327068715 (case), 10195327068714 (unit), Lot Numbers:  22ABP582, 22CBP735, 22JBK237, 22LBK168;   g) REF CVI4705, UDI/DI 40193489832373 (case), 10193489832372 (unit), Lot Numbers: 22CMF740, 22LMH493, 23BMA064, 23HMH653;    h) REF DYNDC2721A, UDI/DI 40195327007080 (case), 10195327005313 (unit), Lot Numbers:  21LBK271, 22ABS686;   i) REF DYNDC2721B, UDI/DI 40195327111091 (case), 10195327111090 (unit), Lot Numbers:  22CBS571, 22DBO302, 22IBG350;   j) REF CVI4720, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23CLA574, 23DLA197;    k) REF CVI4720A, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers: 23DLA715, 23ELB184, 23GLA187;   l) REF CVI4720AH, UDI/DI 20193489199861 (case), 10193489199864 (unit), Lot Numbers:  23DLA715, 23ELB184, 23GLA187;   m) REF DYNDA1584C, UDI/DI 40195327194506 (case), 10195327194505 (unit), Lot Numbers:  22HBB107, 22JBH444, 22KBN619, 22KBU753, 23ABH824, 23CBS036, 23EBD658, 23GBH542, 23IBI230;   n) REF P155508D, UDI/DI 40193489899062 (case), 10193489899061 (unit), Lot Numbers:   22DMC487, 23AMB416, 23BMF491, 23FMD563;     o) REF DT20345A, UDI/DI 40653160991565 (case), 10653160991564 (unit), Lot Numbers:   22ABJ804, 22BBA095, 22IBG184, 22OBE089;    p) REF DYNDC2765B, UDI/DI 40195327039500 (case), 10195327039509 (unit), Lot Numbers:  22ABJ710, 22CBV307, 22CBX726, 22OBA248;   q) REF DYNDC2004B, UDI/DI 40193489999335 (case), 10193489999334 (unit), Lot Numbers:  22ABH197, 22ABK671, 22BBE950, 22DBG182, 22GBD995;   r) REF CVI4730, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers:  22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830;   s) REF CVI4730H, UDI/DI 40193489917407 (case), 10193489917406 (unit), Lot Numbers: 22ABA994, 22BBB180, 22CBX813, 22JBV916, 22KBD924, 22LBN849, 23ABF976, 23BBG923, 23CBN830;   t) REF DYNDC2927A, UDI/DI 40193489943420 (case), 10193489943429 (unit), Lot Numbers:  22BBW666, 22HBT170;   u) REF DYNJ50717, UDI/DI 40889942032373 (case), 10889942032372 (unit), Lot Numbers:  22ABY200, 22HBH109;    v) REF DYNDC2219B, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers:  22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187;   w) REF DYNDC2219BH, UDI/DI 40195327007073 (case), 10195327006068 (unit), Lot Numbers:  22ABN425, 22ABU632, 22BBE945, 22GBA060, 22IBH187;   x) REF CVI4395B, UDI/DI 40653160991633 (case), 10653160991632 (unit), Lot Numbers: 21LBV562, 22CBV268;   y) REF DYNJ906907B, UDI/DI 40195327303526 (case), 10195327303525 (unit), Lot Numbers:  23BMF842;   z) REF DT19740A, UDI/DI 40653160992524 (case), 10653160992523 (unit), Lot Numbers:   22EBE126, 22HBC049, 22IBG224;    aa) REF DYNDH1636, UDI/DI 40193489934879 (case), 10193489934878 (unit), Lot Numbers:  22BBG415, 22DBE305, 22MBA761;   bb) REF MNS13555, UDI/DI 40653160991954 (case). 10653160991953 (unit), Lot Numbers:  22CBE020, 22EBP942;   cc) REF DYNJ64249A, UDI/DI 40193489381369 (case), 10193489381368 (unit), Lot Numbers:  22FLA161;   dd) REF DYNDC2170, UDI/DI 40888277919100 (case), 10888277919099 (unit), Lot Numbers:   22HBO758, 22IBE630, 22LBP013, 23BBF471, 23BBL514, 23GBA859, 23JBD576;   ee) REF DYNDC3251, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers:  22IBG587;   ff) REF DYNDC3251H, UDI/DI 40195327219056 (case), 10195327219055 (unit), Lot Numbers:  22IBG587  gg) REF DYNDC3252, UDI/DI 40195327221141 (case), 10195327221140 (unit), Lot Numbers:  22IBG588;   hh) REF DYNDA2142B, UDI/DI 40195327134168 (case), 10195327134167 (unit), Lot Numbers:  22DBG180, 22EMC030;   ii) REF DYNDC2449B, UDI/DI 40195327010745 (case), 10195327010744 (unit), Lot Numbers:  21LBT939, 22EBP926, 22FBT224;   jj) REF DYNDC3066, UDI/DI 40193489824644 (case), 10193489824643 (unit), Lot Numbers:  22CBD170;   kk) REF DYNDC3103, UDI/DI 40193489962438 (case), 10193489962437 (unit), Lot Numbers:  22HBT222, 22IBG493, 22MBA063;   ll) REF DYNDC3129A, UDI/DI 40195327009831 (case), 10195327009830 (unit), Lot Numbers:  22BBM598, 22CBZ667, 22DMC594, 22DME352;   mm) REF DYNDC3129AH, UDI/DI 40195327009831 (case), 10195327009830 (unit), Lot Numbers:  22BBM598, 22CBZ667, 22DMC594, 22DME352;   nn) REF DT19330B, UDI/DI 40653160992371 (case), 10653160992370 (unit), Lot Numbers:  22OBC582, 22OBE354;   oo) REF DT22785, UDI/DI 40653160992326 (case), 10653160992325 (unit), Lot Numbers:  22CBP076, 22CBS504;   pp) REF DT22780, UDI/DI 40653160992364 (case), 10653160992363 (unit), Lot Numbers:  22DBD209;   qq) REF DYNDC1994C, UDI/DI 40195327083428 (case), 10195327083427 (unit), Lot Numbers:  22ABJ752, 22ABZ148, 22DBD308;   rr) REF DYNDC1994D, UDI/DI 40195327211715 (case), 10195327211714 (unit), Lot Numbers:  22HBT161;   ss) REF DYNDC1994DH, UDI/DI 40195327211715 (case), 10195327211714 (unit), Lot Numbers:  22HBT161;   tt) REF DYNDC2555C, UDI/DI 40195327123421 (case), 10195327123420 (unit), Lot Numbers:  22OBE207;   uu) REF DYNDV2480, UDI/DI 40193489942768 (case), 10193489942767 (unit), Lot Numbers:  22BMG253, 22CMF718, 22CMF720, 22GMB111;   vv) REF DYNDV2480H, UDI/DI 40193489942768 (case), 10193489942767 (unit), Lot Numbers:  22BMG253, 22CMF718, 22CMF720, 22GMB111;   ww) REF DYNDC2078, UDI/DI 40888277262301 (case), 10888277262300 (unit), Lot Numbers:  22EBV407, 22FBL375, 22GBF171;   xx) REF DYNDC2078H, UDI/DI 40888277262301 (case), 10888277262300 (unit), Lot Numbers:  22EBV407, 22FBL375, 22GBF171;   yy) REF DYNDC2657A, UDI/DI 40193489492973 (case), 10193489492972 (unit), Lot Numbers:  22FBU096, 22HBO094, 22IBT553, 23BBI094, 23EBD054, 23FBA804;   zz) REF DYNDC3179, UDI/DI 40195327021444 (case), 10195327021443 (unit), Lot Numbers:  22ABK983, 22ABO532;   aaa)  REF DYNJ69976, UDI/DI 40195327000654 (case), 10195327001308 (unit), Lot Numbers:  22BBW440

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-1097-2024
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-1097-2024 · Source: openFDA enforcement.