|
Class 2 Device Recall Replacement Gastrostomy Device |
|
Date Initiated by Firm |
September 23, 2008 |
Date Posted |
December 12, 2008 |
Recall Status1 |
Terminated 3 on November 08, 2011 |
Recall Number |
Z-0416-2009 |
Recall Event ID |
49523 |
510(K)Number |
K013144
|
Product Classification |
Gastrointestinal Tube (and accessories) - Product Code KNT
|
Product |
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00200W, 16F, 1.2cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.
Dual Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile balloon-type device designed for percutaneous insertion through an established, appropriately sized stoma tract.
The Dual Port Wizard Device is packaged in a kit which also includes two tubes, two gauze pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The inserted device is used for enteral feeding.
|
Code Information |
43AOA018, 43AOA041, 43APA032, 43BOA015, 43BOA037, 43BPA025, 43BQA042, 43BQA184, 43COA013, 43COA036, 43CQA232, 43DOA010, 43DOA037, 43DPAO14, 43DQA063, 43EOA0 13, 43EOA041, 43EPAO13, 43EPA040, 43FOA076, 43FOA107, 43FOA234, 43GOA033, 43GOA009, 43GPA177R, 43GPA178R, 43GPA190R, 43GPA195R, 43HOA031, 43HPA018, 43HPA050, 43HPA223R, 43INA031, 43IOA038, 43IPA017R, 43IPA207R, 43IQA001, 43JNAOO1, 43JNAO44, 43JNA203, 43JNA219, 43JOA014, 43JPA013, 43JPA036, 43KNA012, 43KNA053, 43KOA016, 43KPA013, 43LNAO22, 43LNAO52, 43LOA023, 43LQA001, HURB2525, HURB3526, HURD1915, HURF0483, HURG1443, HURH1078, HURJ0571, HURB2422, HURD0734, HURE0535, HURE2889, HURG1444, and HURJ0594. |
Recalling Firm/ Manufacturer |
C R Bard Inc 605 N 5600 W Salt Lake City UT 84116-3738
|
For Additional Information Contact |
801-595-0700
|
Manufacturer Reason for Recall |
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
|
FDA Determined Cause 2 |
Component design/selection |
Action |
Customers notified by letter (Product Field Action letter) on September 23, 2008 and instructed to remove and return any affected product to Bard Access Systems, Inc (BAS). Customers were instructed in the recall letter to respond by completing and faxing the enclosed Reply Form and Inventory Reconciliation Form. For assistance, contact BAS customer service at 800-290-1689. |
Quantity in Commerce |
1167 units |
Distribution |
Worldwide Distribution including US, Latin America and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = KNT and Original Applicant = C.R. BARD, INC.
|
|
|
|