FDA Device recall Z-1572-2020
1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UD…
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of 1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UD… by Bard Peripheral Vascular, citing 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.….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1572-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-01 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bard Peripheral Vascular |
| Distribution | US |
Product
1. Power Port isp M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1809660, UDI: (01)00801741027154 2. PowerPort isp M.R.I. Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture Plugs, Ref: 1809661, UDI: (01)00801741027161 3. PowerPort isp M.R.I. Implantable Port with Pre-Attached 9.6F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, Ref: 1859660, UDI: (01)00801741027222 4. PowerPort isp M.R.I. Implantable Port with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter without Suture Plugs, Ref: 1859661, UDI: (01)00801741027239 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
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.
Identifiers
| code_info | 1. Lot # for 1809660 - RECT0092 2. Lot # for 1809661 - RECT0190 3. Lot # for 1859660 - RECU0481, RECR0983, RECR1885,…1. Lot # for 1809660 - RECT0092 2. Lot # for 1809661 - RECT0190 3. Lot # for 1859660 - RECU0481, RECR0983, RECR1885, RECR2220, RECS0030, RECS2758 4. Lot # for 1859661 - RECS2974 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1572-2020%22
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