Reported Apr 2, 2014 · Terminated
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system.…
Bard Access Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Access Systems · 605 North 5600 West · Salt Lake City, UT · 84116-3738
Is this the product you have?
- PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system
- Product Codes
17160001716070
- Lot codes and dates
- Lot Numbers
REXA1302REXA1350REXB1160
- Lot Numbers
- Amount recalled
- 777
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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