| | Class 2 Device Recall CardinalHealth Preource |  |
| Date Initiated by Firm | May 29, 2024 |
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| Date Posted | July 10, 2024 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2330-2024 |
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| Recall Event ID |
94763 |
| Product Classification |
Neurological tray - Product Code OJG
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| 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 |
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| 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 |
Recalling Firm/
Manufacturer |
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
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| For Additional Information Contact | customer service
800-551-0533 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Device Design |
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| Action | Cardinal Health issued an URGENT: PRODUCT RECALL notice to its consignees on 05/28/2024 via letter. The notice explained the issue, potential risks involved, and requested the following:
"If you locate affected product within your facility, please complete the following:
1. QUARANTINE affected kits & ALERT your clinicians of this action
2. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard all syringes within the affected Merit Medical kit in the Presource product.
3. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648.
Additional labels will be sent to your facility upon request. Please send an email to:
gmb-FieldCorrectiveAction@cardinalhealth.com
For component credit or replacement, please contact the following:
" Hospitals Cardinal Customer Service at 866.551.0533
" Distributors Distributor Management at 800.635.6021
" Federal Government facilities Government Customer Service at 800.444.1166
If you are a Distributor and have further distributed affected kits, please notify your customers of this recall."
Expansion letter was sent via FedEx Express on 6/20/2024 |
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| Quantity in Commerce | 13487 units |
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| Distribution | Nationwide |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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