Z-2808-2015Class II

Marketing brochures for the PowerPICC and PowerPICC SOLO catheters

Name: Z-2808-2015 Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
Creator: Bard Access Systems
Published: 2015-07-20
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2015-07-20 / Terminated / root cause: labeling and UDI

FDA source

Bard Access Systems began a recall of Marketing brochures for the PowerPICC and PowerPICC SOLO catheters on 2015-07-20. FDA classified it as Class II and gives the reason as "Bard Access Systems is recalling marketing brochures for the PowerPICC and PowerPICC SOLO catheters due to incorrect indication for use contained in the brochure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2808-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-20
Posted: 2015-09-23
Terminated: 2017-02-10
Recalling firm: Bard Access Systems, Inc.
Product: Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Bard Access Systems is recalling marketing brochures for the PowerPICC and PowerPICC SOLO catheters due to incorrect indication for use contained in the brochure.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Customer letter notification with reply form will be sent via Federal Express with delivery confirmation for US consignees on 7/20/15 informing them of the incorrect indication for use contained in the brochure.
Quantity in commerce: 1811
Distribution: Distributed to domestic and foreign conference attendees.
Product codes and lots: The brochures were purchased from the vendor on 04/14/2015, Code S120667R0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2808-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2808-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-30	2015-09-23

Product code LJS

The FDA recall record names no cleared device, and no clearance has been matched to it.

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)