Class I FDA device recall · Z-1101-2024

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) 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

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 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

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-1101-2024
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-1101-2024 · Source: openFDA enforcement.