The Recall Desk
ModerateFDA (Devices)·Z-2808-2015·Announced 2015-09-30

Bard Access Systems Recalls PowerPICC Catheter Marketing Brochures

Bard Access Systems is recalling 1,811 marketing brochures for PowerPICC and PowerPICC SOLO catheters because they contain incorrect indications for use.

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 involves a labeling error (incorrect indication for use) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.

Plain-English summary

Bard Access Systems is recalling 1,811 marketing brochures for the PowerPICC and PowerPICC SOLO catheters. The recall is due to incorrect indications for use contained in the brochures.

The affected brochures were purchased from the vendor on April 14, 2015, and carry the code S120667R0. These materials were distributed to domestic and foreign conference attendees.

Consumers and healthcare professionals who possess these brochures should stop using them for clinical decision-making and contact Bard Access Systems for further instructions.

The recalled product

Product
Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
Affected units
1,811

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 (2)

  • The brochures were purchased from the vendor on 04/14/2015
  • Code S120667R0

Distribution

Distribution scope not specified by the agency.