Presource kits and trays — Class II medical device recall Z-2330-2024
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-2330-2024 |
|---|---|
| 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 | 13,487 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10195594325565, 10195594622534, 10195594755416, 10195594812119, 10195594826031, 10195594854294, 10197106022528, 10197106029121, 10197106029367, 10197106045527, 10197106142912, 10197106182062, 10197106184608, 10197106228258, 10197106251782, 10197106387726, 10197106482223, 10197106550304, 10197106605875, 10887488772707, 10888439636376, 10888439733501, 10888439951806, 50195594325563, 50195594622532 and 21 more |
| Lot numbers | 10096, 103254, 10606, 120832, 127809, 129007, 134410, 140829, 141514, 14350, 156243, 157881, 163637, 168214, 172310, 183868, 203428, 206131, 206874, 213751, 215368, 223186, 224862, 227923, 228005, 236962, 237862, 238196, 238592, 240464, 243572, 247687, 251395, 256027, 257466, 262336, 265553, 267274, 268874, 28512 and 67 more |
| Model numbers | SAN29NICCA, SAN29NRCC1, SAN29NRCC2, SAN29NRCC3, SAN29NRCCA, SANV1NIYH2, SANV1NIYH3, SANV1NIYH4, SANV1NIYH5, SANV1NIYH6, SANV1NIYH7, SANV1NIYHD, SANV1NIYHE, SANV1NIYHF, SANV2INEH4, SANV2INEHG, SANV2INEHH, SNE29NRCCC, SNECGNIUC3, SNEMHNTWD1 |
Product
Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog Number SAN29NRCC1; 3) Neurological Tray, Catalog Number SAN29NRCC2; 4) Neurological Tray, Catalog Number SAN29NRCC3; 5) Neurological Tray, Catalog Number SAN29NRCCA; 6) Neurological Tray, Catalog Number SANV1NIYH2; 7) Neurological Tray, Catalog Number SANV1NIYH3; 8) Neurological Tray, Catalog Number SANV1NIYH4; 9) Neurological Tray, Catalog Number SANV1NIYH5; 10) Neurological Tray, Catalog Number SANV1NIYH6; 11) Neurological Tray, Catalog Number SANV1NIYH7; 12) Neurological Tray, Catalog Number SANV1NIYHD; 13) Neurological Tray, Catalog Number SANV1NIYHE; 14) Neurological Tray, Catalog Number SANV1NIYHF; 15) Neurological Tray, Catalog Number SANV2INEH4; 16) Neurological Tray, Catalog Number SANV2INEHG; 17) Neurological Tray, Catalog Number SANV2INEHH; 18) Neurological Tray, Catalog Number SNE29NRCCC; 19) Neurological Tray, Catalog Number SNECGMEUCA; 20) Neurological Tray, Catalog Number SNECGNIUC3; 21) Neurological Tray, Catalog Number SNECGNIUCA; 22) Neurological Tray, Catalog Number SNEMHNTWD1; 23) Neurological Tray, Catalog Number SNEMHNTWDA
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-2330-2024. 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.