Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device CATALOG #: 01-5799A
FDA Recall Z-1158-2023 · Posted 2023-02-22
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Recalling FirmCardinal Health 200, LLC
Recall StatusOpen, Classified
Product CodeLRS
Date Initiated2022-11-18
Product Quantity36 EA
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
Firm 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
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of GA, PA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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