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Bard Peripheral Vascular Inc recalls BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)008
Recalled April 1, 2020 · FDA recall Z-1576-2020 · Bard Peripheral Vascular
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. · FDA Class II
Units
2493 Catheters
Sold at
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.
Description
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.
Product
BardPort M.R.I. Implantable Port with Attachale 9.6 F Open-Ended Single-Lumen Venous Catheter, REF: 0602680, UDI:(01)00801741025679 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.
Manufacturer(s)
Bard Peripheral Vascular Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →