Cardinal Health Presource Packs IV START KIT- Intended for… recallZ-1157-2023 · Cardinal Health 200, LLC · initiated Nov 18, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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
FDA root cause category: Nonconforming Material/Component
What the company is doing
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
Recall details
- Recall number
- Z-1157-2023
- Status
- Open, Classified
- Initiated by the company
- Nov 18, 2022
- Posted by the FDA
- Feb 22, 2023
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 4560 EA
- Product code
- LRS
- Distribution
- US Nationwide distribution in the states of GA, PA.
Product description
Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B
Code information (models, lots, serial numbers)
UDI-DI: 50195594577153(cs) 10195594577155(ea) Lot Number: 816643 Exp. Date: 2/1/2025
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- CARDINAL HEALTH 01-5798BCardinal Health 200, LLC · I.V. start kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91560).
- Z-1158-2023 · Open, ClassifiedCardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
- Z-1159-2023 · Open, ClassifiedCardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG #: 01A4553E
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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