PowerPort Slim Implantable Port recall: Labeling Error
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Why was PowerPort Slim Implantable Port 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Numbers: REXA1302, REXA1350, REXB1160
- Product
- PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
- Recalling firm
- Bard Access Systems
- Quantity
- 777
- Distribution
- US Nationwide distribution including WA, KY, IL, and IA.
- Recall date
- April 2, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)