Recall Z-1300-2014— Bard Access Systems
Class II · Terminated
Class II FDA medical device recall by Bard Access Systems, initiated 2014-02-27, terminated 2014-09-05. FDA's recall record names no specific 510(k) clearance for this event. Product: PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070. Reason: 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..
- Recalling firm
- Bard Access Systems
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-27
- Terminated
- 2014-09-05
- Firm location
- Salt Lake City, UT, United States
Product description
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.