FDA Device recall Z-0582-2020
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
- FDA Device
- Class II
- ongoing
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter by Bard Peripheral Vascular, citing complaints received that products packaged with the incorrect introducer sheath size.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0582-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-02-14 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
Product
PowerPort isp M.R.I. Implantable Port with Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter
Reason
Complaints received that products packaged with the incorrect introducer sheath size.
Identifiers
| code_info | Product Code: 1808060 Device Listing Number: D004935 UDI: (01)00801741027031(17)191130(10)RECS2407 Lot Number: RECS2407 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0582-2020%22
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