MEDLINE INDUSTRIES, LP - Northfield: 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

Recall number

Z-1101-2024

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

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

Status

Open, Classified

Initiated

2023-11-15

Posted

2024-02-25

Terminated

not on file

Reason

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.

Root cause

Nonconforming Material/Component

Action

MEDLINE issued an IMMEDIATE ACTION REQUIRED NURSE ASSIST PRODUCT RECALL notice to its consignees on 11/16/2023 via USPS first class mail and email. The notice explained the problem, requested log on to their portal to identify the products and check their inventory so the product could be quarantined. Once Medline receives the completed response form, over-labels will be shipped to the consignee. Medline Industries, LP instructed customers to over-label the convenience kits with a warning label indicating to remove the sodium chloride irrigation or Sterile water and replace from a different sterile supply. Distributors or consignees who further distributed the affected products were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.

Quantity

not on file

Distribution

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

Lot, serial or model codes

a) REF CDS983682F; UDI/DI 40193489852975 (case), 10193489852974 (unit), lot Numbers: 22DDA235, 22GBJ113, 23ABQ437, 23EBS939; b) REF DYKE1718A; UDI/DI 40193489494656 (case), 10193489494655 (unit), Lot Numbers: 22FBU098, 22HBM601, 23ABM389; c) REF DYKE1718B; UDI/DI 40195327240128 (case), 10195327240127 (unit), Lot Numbers: 23DBE977; d) REF DYNDC2214G; UDI/DI 40195327051984 (case), 10195327051983 (unit), Lot Numbers: 22ABP471, 22BBO794, 22OBJ991; e) REF DYNJ55334C; UDI/DI 40889942703211 (case), 10889942703210 (unit), Lot Numbers: 22ABL051, 22EBV190, 22FBS394, 23BBA777, 23GBL169; f) REF DYNJ45175B; UDI/DI 40889942485216 (case), 10889942485215 (unit), Lot Numbers: 22CLB148, 22GLB002; g) REF DYNJ59030A; UDI/DI 40195327026203 (cases), 10195327026202 (unit), Lot Numbers: 22DBR838, 22EBO071, 22JBW765, 23FBF261, 23GBC456, 23HBR618; h) REF DYNJ83416; UDI/DI 40195327265053 (cases), 10195327265052 (unit), Lot Numbers: 22LBF471, 23ABN102, 23BBA471; i) REF MNS2895; UDI/DI 50653160062934 (case), 653160062939 (unit), Lot Numbers: 23BBQ180, 23DBN766, 23EBH195, 23FBE540; j) REF MNS2895H; UDI/DI 50653160062934 (case), 653160062939 (unit), Lot Numbers: 23BBQ180, 23DBN766, 23EBH195, 23FBE540; k) REF DYNJ60166C; UDI/DI 40193489467148 (case), 10193489467147 (unit), Lot Numbers: 23ELB099; l) REF CDS983910K; UDI/DI 40195327256594 (case), 10195327256593 (unit), Lot Numbers: 22JBT244, 23ABP271, 23ABP272, 23ABQ792, 23CBE912, 23DBR779, 23FBB371, 23JBL006, 23JBR337; m) REF DYNJ68872C; UDI/DI 40195327375714 (case), 10195327375713 (unit), Lot Numbers: 23DBC646, 23FBA039, 23GBA604, 23HBZ389, 23JBN556; n) REF DYNJ46216J; UDI/DI 40195327407491 (case), 10195327407490 (unit), Lot Numbers: 23EBF873, 23GBO919, 23GBT576, 23IBE145; o) REF CDS984899G; UDI/DI 40193489983822 (case), 10193489983821 (unit), Lot Numbers: 22CLA789; p) REF CDS984899I; UDI/DI 40195327313297 (case), 10195327313296 (unit), Lot Numbers: 23IBV180; q) REF DYNJ65475A; UDI/DI 40193489974578 (case), 10193489974577 (unit), Lot Numbers: 22DBF905; r) REF DYNDC2213F; UDI/DI 40195327052080 (case), 10195327052089 (unit), Lot number: 22ABM936, 22CMG684, 22EMB991; s) REF CDS984895I; UDI/DI 40193489983815 (case), 10193489983814 (unit), Lot Number: 22FBL382, 22IBD790, 23ABM451, 23DBM334; t) REF DYNJ36719C; UDI/DI 40193489265539 (case), 10193489265538 (unit), Lot Numbers: 21LBA818, 21LBU235, 22BBL912; u) REF DYNJ906741B; UDI/DI 40195327055364 (case), 10195327055363 (unit), Lot Numbers: 22ABF704, 22ABL214, 22BBQ966, 22FBY564, 22GBQ902, 22HMI302, 23AMA387, 23AMI317; v) REF CDS983362C; UDI/DI 40193489267342 (case), 10193489267341 (unit), Lot Numbers: 23ABI733; w) REF DYNJ33112I; UDI/DI 40193489402736 (case), 10193489402735 (unit), Lot Numbers: 22DBO140, 22DBO155, 22JBY668, 23BBT134, 23DBT051, 23EBA549, 23HBI328, 23IBM005; x) REF CDS980272L; UDI/DI 40193489616331 (case), 10193489616330 (unit), Lot Numbers: 22NBC732; y) REF DYNDJN001A; UDI/DI 40193489421614 (case), 10193489421613 (unit), Lot Numbers: 22EBB217, 22FBQ070, 22FBU496

510(k) numbers

not on file

PMA numbers

not on file

Product code

OGR

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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