FDA Device recall Z-0001-2024
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2
- FDA Device
- Class I
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class I recall of Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2 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-0001-2024 |
| 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, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic 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 33F23B0781 |
|---|
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-0001-2024%22
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