Recall archive / FDA device enforcement
Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular P... — FDA record Z-2329-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Cardinal Health 200, LLC
- Quantity
- 17445 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2329-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 17, 2024
- Recall initiation date
- May 29, 2024
- Center classification date
- Jul 10, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.