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U.S. Department of Health and Human Services

Class 2 Device Recall Cardinal Health

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  Class 2 Device Recall Cardinal Health see related information
Date Initiated by Firm November 18, 2022
Date Posted February 22, 2023
Recall Status1 Open3, Classified
Recall Number Z-1159-2023
Recall Event ID 91560
Product Classification I.V. start kit - Product Code LRS
Product Cardinal Health Presource Packs IV START KIT-Intended for IV Access
CATALOG #: 01A4553E
Code Information UDI-DI: 50195594389336(ea) 10195594389338(cs) Lot Number: 818636 Exp. Date: 3/1/2024
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
Manufacturer 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
FDA Determined
Cause 2		 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: gmb-FieldCorrectiveAction@cardinalhealth.com 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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