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Bard Access Systems recalls PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Prod
Recalled April 2, 2014 · FDA recall Z-1300-2014 · 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. · FDA Class II
Units
777
Sold at
US Nationwide distribution including WA, KY, IL, and IA.
Description
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.
Product
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Manufacturer(s)
Bard Access Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →