FDA Device recall Z-2396-2026
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711
- FDA Device
- Class I
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class I recall of Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711 by Arrow International, citing lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited rep….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2396-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-04-21 |
| Published | 2026-06-24 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Description/REF: CVC KIT: 16 GA X 8IN/AK-04210, CVC KIT: 1-L 16 GA X 8IN (20 CM)/AK-04300, CVC KIT: 14 GA X 6 IN/CK-04711
Reason
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Identifiers
| code_info | REF(Material)/UDI-DI/Lot(Batch): AK-04210/10801902121582, 10801902193275/33F24A1009, 33F24B0106, 33F24C0009, 33F24D0014…REF(Material)/UDI-DI/Lot(Batch): AK-04210/10801902121582, 10801902193275/33F24A1009, 33F24B0106, 33F24C0009, 33F24D0014, 33F24G0324, 33F24J0490, 33F24K0089, 33F24L0671, 33F25A0456, 33F25C0899, 33F25E0037, 33F25H0011, 33F25J0461; AK-04300/10801902121636, 10801902193275/33F24A1257, 33F24B0435, 33F24C0734, 33F24E0704, 33F24F0011, 33F24G0224, 33F24G0684, 33F24H0373, 33F24M0148, 33F25A0364, 33F25B0084, 33F25D0193, 33F25D0693, 33F25E0479, 33F25H0686, 33F25J0587, 33F25J0651, 33F26C0397; CK-04711/20801902118787, 10801902193275/33F24A0137, 33F24A1212, 33F24B0382, 33F24C0255, 33F24E0572, 33F24G0531, 33F24J0648, 33F24L0731, 33F25A0590, 33F25C0979, 33F25E1039, 33F25J0622, 33F26B0640 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2396-2026%22
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