The Recall Desk
ModerateFDA (Devices)·Z-1579-2020·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the identified hazard is a procedural delay (prolongation of operation) rather than a direct risk of serious injury or death, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Bard Peripheral Vascular Inc is recalling 296 units of the PowerFlow Implatable Apheresis IV Port with attachable 9.6 F ChronoFl x Open-Ended Single-Lumen Venous Catheter (Ref A710962). The recall is limited to Lot # RECR1499. The product is indicated for patient therapies requiring repeated access to the vascular system, including the infusion of medications, I.V. fluids, parenteral nutrition solutions, and blood products.

The firm 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 manufacturing error can result in a prolongation of the surgical operation. The agency has classified this as a Class II recall.

The affected products were distributed worldwide, including nationwide distribution in the United States and in Brazil, Canada, EMEA, Korea, Mexico, and New Zealand. Healthcare providers and patients should contact Bard Peripheral Vascular Inc for further instructions regarding the recall and replacement of the affected devices.

The recalled product

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
Manufacturer
Bard Peripheral Vascular Inc
Category
Medical Device — Implantable Port
Hazard
Affected units
296

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot # RECR1499

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Part of a larger recall action

This product is one of 10 recalled by Bard Peripheral Vascular Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

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