Reported Jul 17, 2024 · Ongoing
Presource kits and trays, labeled as
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
Presource kits and trays, labeled as
23 of 23 products
| Model / number | Product as published |
|---|---|
SAN29NICCA | Neurological Tray |
SAN29NRCC1 | Neurological Tray |
SAN29NRCC2 | Neurological Tray |
SAN29NRCC3 | Neurological Tray |
SAN29NRCCA | Neurological Tray |
SANV1NIYH2 | Neurological Tray |
SANV1NIYH3 | Neurological Tray |
SANV1NIYH4 | Neurological Tray |
SANV1NIYH5 | Neurological Tray |
SANV1NIYH6 | Neurological Tray |
SANV1NIYH7 | Neurological Tray |
SANV1NIYHD | Neurological Tray |
SANV1NIYHE | Neurological Tray |
SANV1NIYHF | Neurological Tray |
SANV2INEH4 | Neurological Tray |
SANV2INEHG | Neurological Tray |
SANV2INEHH | Neurological Tray |
SNE29NRCCC | Neurological Tray |
| — | Neurological Tray, Catalog Number SNECGMEUCA |
SNECGNIUC3 | Neurological Tray |
- Lot codes and dates
23 of 23 products
Products covered by this recall # Barcodes Product as published 1 5019710622825610197106228258SAN29NICCA, UDI/DI (CS/EA) 50197106228256/10197106228258, Lot Numbers: 36457 2 5088843973350910888439733501SAN29NRCC1, UDI/DI (CS/EA) 50888439733509/10888439733501, Lot Numbers: 381858 3 5019559432556310195594325565SAN29NRCC2, UDI/DI (CS/EA) 50195594325563/10195594325565, Lot Numbers: 685160 4 5019559462253210195594622534SAN29NRCC3, UDI/DI (CS/EA) 50195594622532/10195594622534, Lot Numbers: 801575 5 5088843963637410888439636376SAN29NRCCA, 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 5019559481211710195594812119SANV1NIYH2, UDI/DI (CS/EA) 50195594812117/10195594812119, Lot Numbers: 900859 7 5019559485429210195594854294SANV1NIYH3, UDI/DI (CS/EA) 50195594854292/10195594854294, Lot Numbers: 910887 8 5019710602252610197106022528SANV1NIYH4, UDI/DI (CS/EA) 50197106022526/10197106022528, Lot Numbers: 935906 9 5019710618206010197106182062SANV1NIYH5, UDI/DI (CS/EA) 50197106182060/10197106182062, Lot Numbers: 8317 10 5019710618460610197106184608SANV1NIYH6, UDI/DI (CS/EA) 50197106184606/10197106184608, Lot Numbers: 10606 11 5019710655030210197106550304SANV1NIYH7, UDI/DI (CS/EA) 50197106550302/10197106550304, Lot Numbers: 206131 12 5088843995180410888439951806SANV1NIYHD, 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 5019710614291010197106142912SANV1NIYHE, UDI/DI (CS/EA) 50197106142910/10197106142912, Lot Numbers: 141514 14 5019710648222110197106482223SANV1NIYHF, UDI/DI (CS/EA) 50197106482221/10197106482223, Lot Numbers: 157881, 168214, 228005, 237862, 262336, 267274 15 5019710602912910197106029121SANV2INEH4, UDI/DI (CS/EA) 50197106029129/10197106029121, Lot Numbers: 937561 16 5019559475541410195594755416SANV2INEHG, UDI/DI (CS/EA) 50195594755414/10195594755416, Lot Numbers: 927680 17 5019710602936510197106029367SANV2INEHH, UDI/DI (CS/EA) 50197106029365/10197106029367, Lot Numbers: 8892, 10096, 14350, 36037, 120832, 134410, 215368, 224862, 238592, 243572, 967590 18 5088748877270510887488772707SNE29NRCCC, UDI/DI (CS/EA) 50887488772705/10887488772707, Lot Numbers: 236962, 236962, 256027, 257466, 287291, 287291, 318482 19 5019710638772410197106387726SNECGMEUCA, UDI/DI (CS/EA) 50197106387724/10197106387726, Lot Numbers: 98094, 156243 20 5019710660587310197106605875SNECGNIUC3, UDI/DI (CS/EA) 50197106605873/10197106605875, Lot Numbers: 238196 - Amount recalled
- 13487 units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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