Arrow ErgoPack Pressure Injectable One-Lumen PICC — Class II medical device recall Z-2590-2023
Ongoing recall by ARROW INTERNATIONAL Inc., reported 2023-09-27, distributed nationwide. This recall has been initiated due to reports that the product code and product name were incorrectly listed o
| Recall number | Z-2590-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARROW INTERNATIONAL Inc., Morrisville, NC, United States |
| Recall initiated | 2023-08-10 |
| Classified | 2023-09-15 |
| Reported by FDA | 2023-09-27 |
| Distributed | Nationwide (US) |
| Quantity | 190 units |
| Lot numbers | 13F22J0617 |
| Model numbers | CDC-05541-HPK1A |
Product
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Reason for recall
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2590-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.