Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
FDA device recall Z-2808-2015 · posted 2015-09-23 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 1811
- Distribution
- Distributed to domestic and foreign conference attendees.
- Date initiated
- 2015-07-20
- Date posted
- 2015-09-23
- Date terminated
- 2017-02-10
- Location
- Salt Lake City, UT
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