FDA Device recall Z-0002-2024
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A
- FDA Device
- Class I
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class I recall of Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A 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-0002-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-08-10 |
| Published | 2023-10-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Arrow International |
| Distribution | n/a |
Product
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
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 33F23B0723 |
|---|
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-0002-2024%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.