Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage

FDA device recall Z-0815-2014 · posted 2014-01-23 · Terminated

Recall details

Recalling firm

Bard Access Systems

Reason for recall

Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device.

Action taken

BARD sent an Urgent Product Recall letter dated October 2013 to affected customers via certified letter. The letter identified the affected product, problem and actions to be taken. Customers were asked to check all inventory locations, remove and return any unused affected prodcut to Bard Access Systems through return goods authorization number RAP80498 for a credit or replacement, and to complete the Reply Form and Inventory Reconcilation Form. For questions contact BAS Customer Service at 1-800-290-1689.

Root cause

Process control

Status

Terminated

Product code

FOZ

Quantity affected

200

Distribution

Worldwide Distribution - US nationwide, Belgium, and Canada.

Date initiated

2013-12-06

Date posted

2014-01-23

Date terminated

2014-08-05

Location

Salt Lake City, UT