FDA Medical Device Recalls (openFDA)
Bard Access Systems: PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
- Recall number
- Z-1300-2014
- Recalling firm
- Bard Access Systems
- Product
- PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
- Status
- Terminated
- Initiated
- 2014-02-27
- Posted
- 2014-03-27
- Terminated
- 2014-09-05
- Reason
- Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, however approximately 23% of the units contained in the affected lots have a PowerPort Slim titanium implantable port without silicone suture plugs.
- Root cause
- Packaging
- Action
- Notified by Urgent Customer Notification Letter date February 13, 2014, customers were asked to immediately examine their inventory and identify any product subject to this notification. In addition, if they have further distributed this product, please identify customers and notify them at once of this notification. Customers may include a copy of this letter in your notification to customers. Customers may choose to use the involved product with the understanding that the kit may contain a PowerPort Slim implantable port without suture plugs, or may return the applicable product for replacement or credit.
- Quantity
- 777
- Distribution
- US Nationwide distribution including WA, KY, IL, and IA.
- Lot, serial or model codes
- Lot Numbers: REXA1302, REXA1350, REXB1160
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LJT
- 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