Reported Apr 1, 2020 · Terminated
1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs,…
Bard Peripheral Vascular Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Peripheral Vascular Inc · 1625 W 3rd St Bldg 1 · Tempe, AZ · 85281-2438
Is this the product you have?
3 of 3 products
| Model / number | Barcodes | Product as published |
|---|---|---|
1809600 | 00801741027130 | PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, , UDI: (01)00801741027130 |
1809601 | 00801741027147 | PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture Plugs, , UDI: (01)00801741027147 |
1859600 | 00801741027208 | PowerPort M.R.I. Implantable Port With Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, , UDI: (01)00801741027208 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. |
- Lot codes and dates
1. Lot #s 1809600- RECR1434RECT0091 2. Lot #s 1809601- RECT01893. Lot #s 1859600- RECR2072RECS1118
- Amount recalled
- 878 Catheters
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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