FDA Device recall Z-0004-2024
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS
- 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 Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS 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-0004-2024 |
| 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 Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; 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 13F22G0508 |
|---|
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-0004-2024%22
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