PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 1, 2020 Initiated: October 1, 2019 #Z-1572-2020

Product Description

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 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.

Details

Units Affected
824 Catheters
Distribution
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,VA, VT, WA, WI, WV, WY and countries of Brazil, Canada, EMEA, Korea, Mexico, New Zealand.
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Bard Peripheral Vascular Inc. Units affected: 824 Catheters.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 1, 2020. Severity: Moderate. Recall number: Z-1572-2020.