FDA Device recall Z-2591-2023
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS
- FDA Device
- Class II
- ongoing
- Published 2023-09-27
On 2023-09-27 the FDA classified a Class II recall of Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS by Arrow International, citing this recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2591-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-10 |
| Published | 2023-09-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
Reason
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Identifiers
| code_info | Batch/Lot number 13F22E0359 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2591-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.