PowerPort isp M — Class II medical device recall Z-0582-2020
Ongoing recall by Bard Peripheral Vascular Inc, reported 2019-12-04, distributed nationwide. Complaints received that products packaged with the incorrect introducer sheath size.
| Recall number | Z-0582-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Peripheral Vascular Inc, Tempe, AZ, United States |
| Recall initiated | 2019-02-14 |
| Classified | 2019-11-27 |
| Reported by FDA | 2019-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 900 units |
| UPC / GTIN / UDI-DI | 00801741027031 |
| Lot numbers | RECS2407 |
Product
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Reason for recall
Complaints received that products packaged with the incorrect introducer sheath size.
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-0582-2020. 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.