Z-1571-2020 Class II Terminated
Recalled by Bard Peripheral Vascular Inc
— Tempe, AZ
FDA device recall Z-1571-2020 was initiated by Bard Peripheral Vascular Inc on October 1, 2019 and is designated Class II. 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 … The recall status is terminated (terminated February 18, 2022). Affected quantity: 878 Catheters.
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- October 1, 2019
- Termination Date
- February 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 878 Catheters
Product Description
1. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1809600, UDI: (01)00801741027130 ; 2. PowerPort M.R.I. Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter Without Suture Plugs, REF: 1809601, UDI: (01)00801741027147; 3. PowerPort M.R.I. Implantable Port With Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter with Suture Plugs, REF: 1859600, 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.
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.
Distribution Pattern
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.
Code Information
1. Lot #s 1809600- RECR1434, RECT0091 2. Lot #s 1809601- RECT0189, 3. Lot #s 1859600- RECR2072, RECS1118