Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF… — Class II medical device recall Z-1915-2026
Ongoing recall by ARROW INTERNATIONAL, LLC, reported 2026-04-29, distributed nationwide. Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
| Recall number | Z-1915-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ARROW INTERNATIONAL, LLC, Morrisville, NC, United States |
| Recall initiated | 2026-03-11 |
| Classified | 2026-04-22 |
| Reported by FDA | 2026-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
| UPC / GTIN / UDI-DI | 10801902159578, 10801902223668, 10801902223675, 10801902223699 |
| Lot numbers | 33F25L0143, 33F25L0144, 33F25L0145, 33F25M0011 |
| Model numbers | ASK-45854-PUPM1 |
Product
Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC Kit REF ASK-45854-PUPM1 UDI code: (01)10801902159578(17)270531(11)251205(10)33F25M0011 The Arrowg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the Arrowg+ard Blue Plus catheter in preventing CRBSIs compared to the original Arrowg+ard Blue¿ catheter has not been studied
Reason for recall
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
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-1915-2026. 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.