Skip to content
Recall Observatory FDA recall evidence

Device product

PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070

Z-1300-2014

February 27, 2014

Class II

Product summary

Firm
Bard Access Systems
Event
Event 67567
Status
Terminated
Classification
Class II
Quantity
777
Official record key
device-enforcement:Z-1300-2014

Official wording

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.

Code information: Lot Numbers: REXA1302, REXA1350, REXB1160

Distribution pattern: US Nationwide distribution including WA, KY, IL, and IA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.