Recall Z-1300-2014 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Bard Access Systems
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
| Date | Mar 27, 2014 (initiated Feb 27, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Packaging |
| Action | Notified by Urgent Customer Notification Letter date February 13, 2014, customers were asked to immediately examine their inventory and identify any product subject to this notification. In addition, if they have further distributed this product, please identify customers and notify them at once of this notification. Customers may include a copy of this letter in your notification to customers. Customers may choose to use the involved product with the understanding that the kit may contain a PowerPort Slim implantable port without suture plugs, or may return the applicable product for replacem |
| Quantity | 777 |
| Distribution | US Nationwide distribution including WA, KY, IL, and IA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.