FDA Medical Device Recalls (openFDA)
Bard Access Systems: Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
- Recall number
- Z-2808-2015
- Recalling firm
- Bard Access Systems
- Product
- Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
- Status
- Terminated
- Initiated
- 2015-07-20
- Posted
- 2015-09-23
- Terminated
- 2017-02-10
- Reason
- 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
- 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
- 1811
- Distribution
- Distributed to domestic and foreign conference attendees.
- Lot, serial or model codes
- The brochures were purchased from the vendor on 04/14/2015, Code S120667R0
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LJS
- Firm FEI
- 3006260740
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28