Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
FDA Recall Z-2808-2015 · Posted 2015-09-23
Recalling FirmBard Access Systems
Recall StatusTerminated
Product CodeLJS
Date Initiated2015-07-20
Date Terminated2017-02-10
Product Quantity1811
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.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
Distributed to domestic and foreign conference attendees.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.