1 — Class II medical device recall Z-1578-2020
Terminated recall by Bard Peripheral Vascular Inc, reported 2020-04-01, distributed nationwide. Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant
| Recall number | Z-1578-2020 |
|---|---|
| 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 | 2019-10-01 |
| Classified | 2020-03-26 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2022-02-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, KR, MX, NZ |
| Quantity | 225 catheters |
| UPC / GTIN / UDI-DI | 00801741026195, 00801741026379 |
| Lot numbers | 0607550, RECR1508, RECU1597 |
| Model numbers | 0607550, 0657525 |
Product
1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. 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
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
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-1578-2020. 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.