Device recall: Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B

Class II FDA enforcement event 91560. Recall start date: 18 Nov 2022. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Cardinal Health 200, LLC started this device recall on 18 Nov 2022. The firm address in the FDA record is in Waukegan, IL. FDA put the recall in Class II. FDA event 91560 has 3 product records. The first FDA enforcement report date is 1 Mar 2023. The record gives the status Ongoing.

FDA enforcement report The 3 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 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide distribution in the states of GA, PA.

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

3 product records in the event.

FDA event 91560: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1157-2023	Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B	4560 EA	Class II	Ongoing	1 Mar 2023
Z-1158-2023	Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A	36 EA	Class II	Ongoing	1 Mar 2023
Z-1159-2023	Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E	31,300 EA	Class II	Ongoing	1 Mar 2023

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 II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2022: 839
Share of these events in Class II: 88%
Product records in this event: 3Median 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
Initiated	Product (first record)	Type	Class	Records
29 Jul 2026	Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catal	Device	Class II	12
14 Jul 2026	Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number:	Device	Class II	8
2 Mar 2026	Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Wa	Drug	Class I	1
27 Feb 2026	Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777	Device	Class II	1
26 Dec 2025	Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 888857	Device	Class II	1
12 Nov 2025	ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-st	Device	Class II	1
18 Sep 2025	Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SA	Device	Class II	6
13 May 2025	SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Con	Device	Class II	3
2 May 2025	Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs	Device	Class II	6
8 Nov 2024	Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGH	Device	Class II	10

Cardinal Health 200, LLC: all 59 events

Official channels

FDA enforcement report Z-1157-2023The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 91560. https://recallregister.com/fda/ii/91560/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

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: US Nationwide distribution in the states of GA, PA.
What quantity of product is in FDA event 91560?: The event has 3 product records. The first record gives this quantity: 4560 EA
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2022 have the same class?: 88% of the 839 device events that started in 2022 are in Class II.