—#208358

Product

Presource 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

FDA product code: OEZ — Cardiovascular Procedure Kit
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

Cardinal 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

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2024-05-29
Posted by FDA: 2024-07-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208358. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.