MEDLINE Kits — Class I medical device recall Z-1101-2024
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-1101-2024 |
|---|---|
| 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 | 00653160062939, 10193489265538, 10193489267341, 10193489402735, 10193489421613, 10193489467147, 10193489494655, 10193489616330, 10193489852974, 10193489974577, 10193489983814, 10193489983821, 10195327026202, 10195327051983, 10195327052089, 10195327055363, 10195327240127, 10195327256593, 10195327265052, 10195327313296, 10195327375713, 10195327407490, 10889942485215, 10889942703210, 40193489265539 and 23 more |
| Lot numbers | 21LBA818, 21LBU235, 22ABF704, 22ABL051, 22ABL214, 22ABM936, 22ABP471, 22BBL912, 22BBO794, 22BBQ966, 22CLA789, 22CLB148, 22CMG684, 22DBF905, 22DBO140, 22DBO155, 22DBR838, 22DDA235, 22EBB217, 22EBO071, 22EBV190, 22EMB991, 22FBL382, 22FBQ070, 22FBS394, 22FBU098, 22FBU496, 22FBY564, 22GBJ113, 22GBQ902, 22GLB002, 22HBM601, 22HMI302, 22IBD790, 22JBT244, 22JBW765, 22JBY668, 22LBF471, 22NBC732, 22OBJ991 and 44 more |
| Model numbers | CDS980272L, CDS983362C, CDS983682F, CDS983910K, CDS984895I, CDS984899G, CDS984899I, DYKE1718A, DYKE1718B, DYNDC2213F, DYNDC2214G, DYNDJN001A, DYNJ33112I, DYNJ36719C, DYNJ45175B, DYNJ46216J, DYNJ55334C, DYNJ59030A, DYNJ60166C, DYNJ65475A, DYNJ68872C, DYNJ83416, DYNJ906741B, MNS2895, MNS2895H |
Product
MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B; d) DOUBLE CENTRAL LINE CAP CHANGE, REF DYNDC2214G; e) ENT PACK, REF DYNJ55334C; f) ENT PACK, REF DYNJ45175B; g) ENT PACK, REF DYNJ59030A; h) ENT PACK, REF DYNJ83416; i) ENT/EPISTAXIS TRAY, REF MNS2895; j) ENT/EPISTAXIS TRAY, REF MNS2895H; k) HEAD & NECK PACK, REF DYNJ60166C; l) HEAD AND NECK CDS, REF CDS983910K; m) HEAD AND NECK PACK, REF DYNJ68872C; n) HEAD AND NECK PACK, REF DYNJ46216J; o) NASAL, REF CDS984899G; p) NASAL, REF CDS984899I; q) PACK,BRONCHOSCOPY, REF DYNJ65475A; r) SINGLE CENTRAL LINE CAP CHANGE, REF DYNDC2213F; s) T & A, REF CDS984895I; t) T AND A, REF DYNJ36719C; u) T AND A, REF DYNJ906741B; v) T AND A CDS, REF CDS983362C; w) T&A PACK, REF DYNJ33112I; x) TONSIL CDS-LF, REF CDS980272L; y) TRACH CARE KIT, REF DYNDJN001A
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-1101-2024. 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.