Presource kits and trays — Class II medical device recall Z-2329-2024
Ongoing recall by Cardinal Health 200, LLC, reported 2024-07-17, distributed nationwide. Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Me
| Recall number | Z-2329-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2024-05-29 |
| Classified | 2024-07-10 |
| Reported by FDA | 2024-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 17,445 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10195594056346, 10195594100889, 10195594650865, 10197106375563, 10197106394403, 10887488572079, 10888439692860, 10888439791921, 10888439916935, 10888439972535, 50195594056344, 50195594100887, 50195594650863, 50197106375561, 50197106394401, 50887488572077, 50888439692868, 50888439791929, 50888439916933, 50888439972533 |
| Lot numbers | 104936, 105901, 106300, 117262, 124487, 124750, 137706, 149856, 164959, 166138, 184313, 186438, 192358, 195004, 203053, 213752, 227924, 228035, 247566, 248336, 25179, 257038, 265705, 268411, 27481, 29199, 295823, 330354, 35435, 377162, 404590, 441771, 470382, 47777, 485647, 51272, 52789, 538664, 583559, 60783 and 40 more |
| Model numbers | SAN29ANCC3, SAN29ANCC4, SAN29ANCCL, SAN29ANCCM, SAN33CDCAS, SAN33CDCAT, SAN73LHKC6, SAN73LHKCC, SCV29ANCCA |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2329-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.