Recall Register

Device recall: Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE

Class I FDA enforcement event 93676. Recall start date: . Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.

Class I, in the words of FDA

a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death

Cardinal Health 200, LLC started this device recall on 28 Dec 2023. The firm address in the FDA record is in Waukegan, IL. FDA put the recall in Class I. FDA event 93676 has 13 product records. The first FDA enforcement report date is 14 Feb 2024. The record gives the status Ongoing.

FDA enforcement reportThe 13 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.

Recalling firm

Cardinal Health 200, LLC, Waukegan, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

13 product records in the event.

FDA event 93676: product records
Recall numberProductQuantityClassStatusReport date
Z-0847-2024Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE20186 unitsClass IOngoing14 Feb 2024
Z-0848-2024Cardinal Health Monoject, 12mL Enteral Syringe (purple) For Use with ENFit Connection System, REF 412SE60760 unitsClass IOngoing14 Feb 2024
Z-0849-2024Cardinal Health Monoject, 35mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 435SE223056 unitsClass IOngoing14 Feb 2024
Z-0850-2024Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE397676 unitsClass IOngoing14 Feb 2024
Z-0851-2024Cardinal Health Monoject, 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, REF 1180100777Class IOngoing14 Feb 2024
Z-0852-2024Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777Class IOngoing14 Feb 2024
Z-0853-2024Cardinal Health Monoject, 6 mL Syringe Luer-Lock Tip Soft Pack, REF 1180600777Class IOngoing14 Feb 2024
Z-0854-2024Cardinal Health Monoject, 12 mL Syringe Luer-Lock Tip Soft Pack, REF 1181200777TClass IOngoing14 Feb 2024
Z-0855-2024Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777Class IOngoing14 Feb 2024
Z-0856-2024Cardinal Health Monoject, 35 mL Syringe Luer-Lock Tip Soft Pack, REF 1183500777Class IOngoing14 Feb 2024
Z-0857-2024Cardinal Health Monoject, 60 mL Syringe Luer-Lock Tip Soft Pack, REF 1186000777TClass IOngoing14 Feb 2024
Z-0858-2024Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SEClass IOngoing14 Feb 2024
Z-0859-2024Cardinal Health Monoject, 3 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 403SEClass IOngoing14 Feb 2024

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2023
917
Share of these events in Class I
10%
Product records in this event
13Median of the firm: 3
Events of the firm on the register
59

Other events of the firm

Other FDA enforcement events of Cardinal Health 200, LLC
InitiatedProduct (first record)TypeClassRecords
29 Jul 2026Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , CatalDeviceClass II12
14 Jul 2026Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number:DeviceClass II8
2 Mar 2026Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, WaDrugClass I1
27 Feb 2026Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777DeviceClass II1
26 Dec 2025Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 888857DeviceClass II1
12 Nov 2025ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-stDeviceClass II1
18 Sep 2025Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SADeviceClass II6
13 May 2025SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow ConDeviceClass II3
2 May 2025Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCsDeviceClass II6
8 Nov 2024Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDeviceClass II10

Cardinal Health 200, LLC: all 59 events

Official channels

Cite this page

Recall Register. FDA enforcement event 93676. https://recallregister.com/fda/i/93676/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA device enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada.
What quantity of product is in FDA event 93676?
The event has 13 product records. The first record gives this quantity: 20186 units
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many device recalls of 2023 have the same class?
10% of the 917 device events that started in 2023 are in Class I.