FDAFDA · Food and drugs·Recall number Z-1300-2014
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Published April 2, 2014 · Recall initiated: February 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Access Systems
- Distributor
- US Nationwide distribution including WA, KY, IL, and IA.
- Lot
- Lot Numbers: REXA1302, REXA1350, REXB1160
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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