5 — Class II medical device recall Z-3200-2018
Terminated recall by Arrow International Inc, reported 2018-09-26, distributed in AL, AZ, CA, GA, MA, MD, ME, MI…. The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may c
| Recall number | Z-3200-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2018-07-17 |
| Classified | 2018-09-19 |
| Reported by FDA | 2018-09-26 |
| Terminated | 2020-12-02 |
| Distributed | AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, WA |
| Quantity | 1,257 total |
Product
5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2
Reason for recall
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.
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-3200-2018. 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.