PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Product Codes: 1716000, 1716070
This recall has been terminated (originally issued March 27, 2014).
- Company
- Bard Access Systems
- Recall Initiated
- February 27, 2014
- Posted
- March 27, 2014
- Terminated
- September 5, 2014
- Recall Number
- Z-1300-2014
- Quantity
- 777
- Firm Location
- West Salt Lake City, UT
- Official Source
- View on FDA website ↗
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.
Distribution
US Nationwide distribution including WA, KY, IL, and IA.
Lot / Code Info
Lot Numbers: REXA1302, REXA1350, REXB1160
Root Cause
Packaging
Action Taken
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 replacement or credit.