The Recall Desk

FDA (Devices) recall action 84914

Bard Peripheral Vascular Inc recalled 10 products on 2020-04-01

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products
10
Announced
2020-04-01
Critical
0
Units
6,653

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–10 of 10

  • ModerateFDA (Devices)··2020-04-01

    BardPort M.R.I. Hard Base Implantable Port Recall Due to Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 151 BardPort M.R.I. Hard Base Implantable Ports because they may contain an incorrect tunneler barb tip, potentially prolonging surgical operations.

    Product
    BardPort M.R.I. Hard Base Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter, Ref: 0604550, UDI: (01)00801741025860 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port sy
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2020-04-01

    BardPort Titanium Implantable Port Recall Due to Incorrect Catheter Tip

    Bard Peripheral Vascular Inc is recalling 360 BardPort Titanium Implantable Ports because they may contain an incorrect catheter tip, potentially prolonging surgery.

    Product
    BardPort Titanium Implantable Port with Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter , REF: 0602230, UDI: (01)00801741025563 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The port system ca
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2020-04-01

    Bard Groshong Dual-Lumen Catheters Recalled for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 650 Groshong 9.5 Dual-Lumen CV Catheters because they may contain an incorrect tunneler barb tip, potentially prolonging surgical operations.

    Product
    1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen CV Catheter, REF: 7726954, UDI: (01)00801741041587
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2020-04-01

    Bard PowerPort Implantable Ports Recalled Due to Incorrect Catheter Barb Tip

    Bard Peripheral Vascular Inc is recalling 178 PowerPort implantable ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgery.

    Product
    1.PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single-Lumen Venous Catheter REF: 1709600, Air Guard, With suture Plugs, (01)00801741026720; 2. PowerPort Implantable Port With Attachable 9.6 F Open-Ended Single- Lumen Venous Catheter, REF: 1709601, Air Guard, Wit
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2020-04-01

    Bard X-Port isp MRI Implantable Port Recall for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 225 X-Port isp MRI Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    1. X-Port isp M.R.I Implantable Port, with Pre-Attached 9.6 F Open-Ended Single-Lumen Venous Catheter, REF:0607550, UDI:(01)00801741026195 2. X-Port isp M.R.I. Implantable Port, with Attachable 9.6F Open-Ended Single-Lumen Venous Catheter, REF: 0657525, UDI:(01)00801741026379 P
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2020-04-01

    Bard PowerFlow Apheresis IV Port Recalled for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 296 PowerFlow Implatable Apheresis IV Ports because they may contain an incorrect tunneler tip, potentially prolonging surgical operations.

    Product
    PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter, Ref A710962, UDI:(01)00801741129438 Product Usage: Bard implantable ports are indicated for patient therapies requiring repeated access to the vascular system. The p
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2020-04-01

    BardPort M.R.I. Implantable Port Recall Due to Incorrect Catheter Tip

    Bard Peripheral Vascular Inc is recalling BardPort M.R.I. Implantable Ports because they may contain an incorrect catheter tip, potentially prolonging surgical operations.

    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
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2020-04-01

    Bard PowerPort isp MRI Implantable Port Recall for Incorrect Catheter Barb Tip

    Bard Peripheral Vascular Inc is recalling 824 PowerPort isp MRI Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    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
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2020-04-01

    Bard Vaccess CT Implantable Port Recall Due to Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 598 Vaccess CT Power-Injectable Implantable Ports because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    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 medicat
    Category
    Distribution
    49 states
  • ModerateFDA (Devices)··2020-04-01

    Bard PowerPort M.R.I. Implantable Port Catheter Recall for Incorrect Tunneler Tip

    Bard Peripheral Vascular Inc is recalling 878 PowerPort M.R.I. Implantable Port catheters because they may contain a tunneler with an incorrect barb tip, potentially prolonging surgical operations.

    Product
    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,
    Category
    Distribution
    49 states