Z-1159-2023Class II

Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E

Name: Z-1159-2023 Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
Creator: Cardinal Health 200, LLC
Published: 2022-11-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-11-18 / Open, Classified / root cause: manufacturing process

FDA source

Cardinal Health 200, LLC began a recall of Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E on 2022-11-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1159-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-11-18
Posted: 2023-02-22
Recalling firm: Medtronic, Inc.
Product: Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
Product code: LRS I.V. Start Kit
Reason for recall: 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
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Cardinal Health issued Urgent: Product Correction letter and Acknowledgement Form was sent overnight on November 18, 2022 to the direct consignees. Letter states reason for recall, health risk and action to take: If you locate affected product within your facility, please do the following: 1. QUARANTINE affected kits. 2. ALERT your clinicians of this action. 3. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s). 4. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648. Additional labels will be sent to your facility upon request. Please send an email to: [email protected] For component credit or replacement, please contact the following: " Hospitals Cardinal Customer Service at 866.551.0533 " Distributors Distributor Management at 800.635.6021 " Federal Government facilities Government Customer Service at 800.444.1166 If you are a Distributor and have further distributed affected kits please notify your customers of this recall. We sincerely apologize for any inconvenience this notice may have caused you and your staff. Should you have any questions, require additional labels or desire special assistance relating to this recall, please feel free to contact Cardinal Health Quality Systems at 800.292.9332
Quantity in commerce: 31,300 EA
Distribution: US Nationwide distribution in the states of GA, PA.
Product codes and lots: UDI-DI: 50195594389336(ea) 10195594389338(cs) Lot Number: 818636 Exp. Date: 3/1/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1159-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1157-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-22
Z-1158-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-22
Z-1159-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-01	2023-02-22

Product code LRS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)