FDA Device recall Z-2395-2026
Description/REF: PICC ACCESS TRAY/ASK-04001-CG1
- FDA Device
- Class I
- ongoing
- Published 2026-06-24
On 2026-06-24 the FDA classified a Class I recall of Description/REF: PICC ACCESS TRAY/ASK-04001-CG1 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-2395-2026 |
| 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: PICC ACCESS TRAY/ASK-04001-CG1
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): ASK-04001-CG1/10801902193275/33F25C0224, 33F25D0647, 33F25G0390, 33F25J0348 |
|---|
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-2395-2026%22
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