FDA-Device2020-04-01Class II
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
Bard Peripheral Vascular Inc
Hazard
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.
Sold states
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.
Affected count
824 Catheters
Manufactured in
1625 W 3rd St Bldg 1, N/A, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1572-2020Don't want to check this manually?
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