1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 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.
Enforcement
- Recall Number
- Z-1573-2020
- Event ID
- 84914
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Bard Peripheral Vascular Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 1, 2020
- Initiation Date
- October 1, 2019
- Classification Date
- March 26, 2020
- Termination Date
- February 18, 2022
- Address
- 1625 W 3rd St Bldg 1, N/A, Tempe, AZ, 85281-2438, United States
Description
1. Vaccess CT Power-Injectable Implantable Port with Suture Plugs, Ref: 7496000, UDI:(01)00801741027482 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.
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.
Lot # RECR0929, RECR1511, RECR1882
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.
598 Catheters