PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access to the vascular system. Produ

FDA device recall Z-1300-2014 · posted 2014-03-27 · Terminated

Recall details

Recalling firm

Bard Access Systems

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.

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.

Root cause

Packaging

Status

Terminated

Product code

LJT

Quantity affected

777

Distribution

US Nationwide distribution including WA, KY, IL, and IA.

Date initiated

2014-02-27

Date posted

2014-03-27

Date terminated

2014-09-05

Location

Salt Lake City, UT