PowerPort duo M — Class II medical device recall Z-1552-2021
Terminated recall by Bard Peripheral Vascular Inc, reported 2021-05-19, distributed nationwide. Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
| Recall number | Z-1552-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2021-03-25 |
| Classified | 2021-05-10 |
| Reported by FDA | 2021-05-19 |
| Terminated | 2023-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 287 units |
| UPC / GTIN / UDI-DI | 00801741027406 |
| Model numbers | 5829502 |
Product
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 5829502, UDI: (01)00801741027406 - Product Usage: The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
Reason for recall
Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
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-1552-2021. 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.