MEDLINE Kits — Class I medical device recall Z-1097-2024
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2024-03-06, distributed nationwide. Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse
| Recall number | Z-1097-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-11-15 |
| Classified | 2024-02-24 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, PA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10193489199864, 10193489381368, 10193489492972, 10193489824643, 10193489832372, 10193489899061, 10193489917406, 10193489934878, 10193489942767, 10193489943429, 10193489962437, 10193489999235, 10193489999334, 10195327001308, 10195327004255, 10195327005313, 10195327006068, 10195327009830, 10195327010744, 10195327021443, 10195327039509, 10195327068714, 10195327083427, 10195327111090, 10195327120597 and 60 more |
| Lot numbers | 21LBK271, 21LBT939, 21LBV562, 22ABA994, 22ABH197, 22ABH235, 22ABJ710, 22ABJ752, 22ABJ804, 22ABK671, 22ABK983, 22ABN425, 22ABO532, 22ABP582, 22ABS686, 22ABU632, 22ABY200, 22ABZ109, 22ABZ148, 22BBA095, 22BBB180, 22BBE945, 22BBE950, 22BBF113, 22BBG415, 22BBK108, 22BBM598, 22BBW440, 22BBW666, 22BMG253, 22CBD170, 22CBE020, 22CBP076, 22CBP735, 22CBS504, 22CBS571, 22CBV268, 22CBV307, 22CBX726, 22CBX813 and 91 more |
| Model numbers | CVI4395B, CVI4705, CVI4720, CVI4720A, CVI4720AH, CVI4730, CVI4730H, CVI4805, DT19330B, DT19740A, DT20345A, DT22710, DT22780, DT22785, DYNDA1584C, DYNDA2142B, DYNDC1994C, DYNDC1994D, DYNDC1994DH, DYNDC2002A, DYNDC2004B, DYNDC2078, DYNDC2078H, DYNDC2170, DYNDC2219B and 28 more |
Product
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1097-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.