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U.S. Department of Health and Human Services

Class 2 Device Recall CardinalHealth Preource

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 Class 2 Device Recall CardinalHealth Preourcesee related information
Date Initiated by FirmMay 29, 2024
Date PostedJuly 10, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2329-2024
Recall Event ID 94763
Product Classification Cardiovascular procedure kit - Product Code OEZ
ProductPresource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC4; 3) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCL; 4) Cardiovascular Procedure Kit, Catalog Number SAN29ANCCM; 5) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAS; 6) Cardiovascular Procedure Kit, Catalog Number SAN33CDCAT; 7) Cardiovascular Procedure Kit, Catalog Number SANOCAENSA; 8) Cardiovascular Procedure Kit, Catalog Number SCV29ANCCA; 9) Left Heart Kit, Catalog Number SAN73LHKCC; 10) Left Heart Kit, Catalog Number SAN73LHKC6
Code Information 1) SAN29ANCC3, UDI/DI (CS/EA) 50888439692868/10888439692860, Lot Numbers: 377162; 2) SAN29ANCC4, UDI/DI (CS/EA) 50888439791929/10888439791921, Lot Numbers: 404590; 3) SAN29ANCCL, UDI/DI (CS/EA) 50887488572077/10887488572079, Lot Numbers: 227924, 248336, 268411, 295823, 330354, 441771, 470382, 485647; 4) SAN29ANCCM, UDI/DI (CS/EA) 50888439916933/10888439916935, Lot Numbers: 538664; 5) SAN33CDCAS, UDI/DI (CS/EA) 50195594100887/10195594100889, Lot Numbers: 7500, 27481, 47777, 66619, 84103, 98759, 654804, 664274, 670490, 690813, 719128, 742731, 769997, 789979, 806872, 821751, 853574, 892089, 905085, 929736, 955110, 974399, 989732; 6) SAN33CDCAT, UDI/DI (CS/EA) 50197106394401/10197106394403, Lot Numbers: 105901, 124750, 166138, 184313, 213752, 228035, 247566; 7) SANOCAENSA, UDI/DI (CS/EA) 50195594650863/10195594650865, Lot Numbers: 60783, 75070, 104936, 117262, 149856, 164959, 192358, 195004, 265705, 842090, 846704, 868814; 8) SCV29ANCCA, UDI/DI (CS/EA) 50888439972533/10888439972535, Lot Numbers: 35435, 51272, 106300, 186438, 257038, 583559, 619303, 639545, 668446, 721926, 744092, 783887, 806636, 868787, 896632, 933968, 969941, 985419; 9) SAN73LHKCC, UDI/DI (CS/EA) 50195594056344/10195594056346, Lot Numbers: 25179, 29199, 52789, 124487, 137706, 203053, 756293, 826474; 10) SAN73LHKC6, UDI/DI (CS/EA) 50197106375561/10197106375563, Lot Numbers: 89496
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information Contactcustomer service
800-551-0533
Manufacturer Reason
for Recall		Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied finished kits. Merit Medical supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device.
FDA Determined
Cause 2		Device Design
ActionCardinal Health issued an URGENT: PRODUCT RECALL notice to its consignees on 05/28/2024 via letter. The notice explained the issue, potential risks involved, and requested the following: "If you locate affected product within your facility, please complete the following: 1. QUARANTINE affected kits & ALERT your clinicians of this action 2. 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 all syringes within the affected Merit Medical kit in the Presource product. 3. 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." Expansion letter was sent via FedEx Express on 6/20/2024
Quantity in Commerce17445 units
DistributionNationwide
Total Product Life CycleTPLC 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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