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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Bard Access Systems
- Hazard
- 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.
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