FDA-Device2014-04-02Class II
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Bard Access Systems
Hazard
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.
Sold states
US Nationwide distribution including WA, KY, IL, and IA.
Affected count
777
Manufactured in
605 North 5600 West, N/A, Salt Lake City, UT, United States
Products
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1300-2014Don't want to check this manually?
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