Class II FDA device recall · Z-2330-2024

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

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

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.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

1) SAN29NICCA, UDI/DI (CS/EA) 50197106228256/10197106228258, Lot Numbers:  36457;  2) SAN29NRCC1, UDI/DI (CS/EA) 50888439733509/10888439733501, Lot Numbers:  381858;  3) SAN29NRCC2, UDI/DI (CS/EA) 50195594325563/10195594325565, Lot Numbers:  685160;  4) SAN29NRCC3, UDI/DI (CS/EA) 50195594622532/10195594622534, Lot Numbers:  801575;  5) SAN29NRCCA, UDI/DI (CS/EA) 50888439636374/10888439636376, Lot Numbers:  28512, 42260, 69660, 85314, 103254, 127809, 140829, 183868, 213751, 227923, 240464, 251395, 268874, 345018, 393999, 409767, 428188, 443499, 450337, 493647, 516110, 532267, 558093, 579539, 607101, 629107, 653793, 713103, 736984, 760148, 840293, 860356, 884815, 911567, 927802, 951008, 972525;  6) SANV1NIYH2, UDI/DI (CS/EA) 50195594812117/10195594812119, Lot Numbers: 900859;  7) SANV1NIYH3, UDI/DI (CS/EA) 50195594854292/10195594854294, Lot Numbers:  910887;  8) SANV1NIYH4, UDI/DI (CS/EA) 50197106022526/10197106022528, Lot Numbers:  935906;  9) SANV1NIYH5, UDI/DI (CS/EA) 50197106182060/10197106182062, Lot Numbers:  8317;  10) SANV1NIYH6, UDI/DI (CS/EA) 50197106184606/10197106184608, Lot Numbers:  10606;  11) SANV1NIYH7, UDI/DI (CS/EA) 50197106550302/10197106550304, Lot Numbers:  206131;  12) SANV1NIYHD, UDI/DI (CS/EA) 50888439951804/10888439951806, Lot Numbers:  586552, 619022, 623318, 643076, 665586, 708746, 735601, 759729, 779438, 791843, 822259, 841189, 863424, 884486, 892439, 952549, 960592, 980278, 982298;  13) SANV1NIYHE, UDI/DI (CS/EA) 50197106142910/10197106142912, Lot Numbers:  141514;  14) SANV1NIYHF, UDI/DI (CS/EA) 50197106482221/10197106482223, Lot Numbers:  157881, 168214, 228005, 237862, 262336, 267274;  15) SANV2INEH4, UDI/DI (CS/EA) 50197106029129/10197106029121, Lot Numbers:  937561;  16) SANV2INEHG, UDI/DI (CS/EA) 50195594755414/10195594755416, Lot Numbers:  927680;  17) SANV2INEHH, UDI/DI (CS/EA) 50197106029365/10197106029367, Lot Numbers:  8892, 10096, 14350, 36037, 120832, 134410, 215368, 224862, 238592, 243572, 967590;  18) SNE29NRCCC, UDI/DI (CS/EA) 50887488772705/10887488772707, Lot Numbers:  236962, 236962, 256027, 257466, 287291, 287291, 318482;  19) SNECGMEUCA, UDI/DI (CS/EA) 50197106387724/10197106387726, Lot Numbers:  98094, 156243;  20) SNECGNIUC3, UDI/DI (CS/EA) 50197106605873/10197106605875, Lot Numbers:  238196;  21) SNECGNIUCA, UDI/DI (CS/EA) 50197106045525/10197106045527, Lot Numbers:  48591, 172310, 203428, 223186, 247687, 265553, 980874;  22) SNEMHNTWD1, UDI/DI (CS/EA) 50197106251780/10197106251782, Lot Numbers:  37065;  23) SNEMHNTWDA, UDI/DI (CS/EA) 50195594826039/10195594826031, Lot Numbers:  129007, 163637, 206874, 938377, 972171

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

Nationwide

Recall record

Recalling firm: Cardinal Health 200, LLC
Product type: Devices
Recall number: Z-2330-2024
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Waukegan, IL
Recall initiated: 2024-05-29

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-2330-2024 · Source: openFDA enforcement.