Class II Recall

Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA; 2) Neurological Tray, Catalog

Summary

The FDA issued a Class II for Presource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN by Cardinal Health 200, LLC. Reason: Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syring.

Details

Source

Device Recall

External ID

Z-2330-2024

Action Date

2024-07-17

Status

Ongoing

Product Description

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

Lot/Code Info: 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

Quantity Affected: 13487 units

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.

Distribution

Nationwide

Type: Voluntary: Firm initiated

Recall Initiated: 2024-05-29

Company

Cardinal Health 200, LLC

Waukegan, IL

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 188 device recalls issued in the same week, part of 413 device-related FDA actions this month.

Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 clearance.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cardinal Health 200, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Cardinal Health 200, LLC have FDA actions?

Cardinal Health 200, LLC has 153 FDA actions in our database, including 152 recalls and 1 device clearance.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2330-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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