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U.S. Department of Health and Human Services

Class 2 Device Recall Replacement Gastrostomy Device

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  Class 2 Device Recall Replacement Gastrostomy Device see related information
Date Initiated by Firm September 23, 2008
Date Posted December 12, 2008
Recall Status1 Terminated 3 on November 08, 2011
Recall Number Z-0423-2009
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 00207W, 20F, 4.4cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.
Code Information 43APA015,  43APA038,  43ARA285,  43ARA290,  43BOA023,  43BPA013,  43COA020,  43CQA025,  43DOA022,  43DPA023,  43DPA047,  43DPA225,  43DQA018,  43EQA018,  43EQA053,  43EQA205,  43FOA090,  43FPA177,  43GOA018,  43GPA150,  43GPA200R,  43GQA011,  43GQA191,  43HOA017,  43HOA035,  43HPA026,  43HPA027,  43HQA009 43INA017,  43INA038,  43IOA021,  43I0A043,  43IPA025,  43IPA046,  43IPA200R,  43IQA008,  43IQA031,  43JNA006,  43JNA048,  43JOA004,  43JOA020,  43JPA021,  43JPA041,  43JQA007,  43KNA018 43KNA057,  43KOA020,  43KPA019,  43KQA033,  43LNA027,  43LOA010,  43LOA030,  43LOA008,  HURA1321,  HURB2536,  HURB4365,  HURB4366,  HURD0671,  HURD0672,  HURD1928,  HURE2906,  HURF0496,  HURG1454,  HURH1091,  HURJ0604,  HURJ1586,  HURK1513, and  HURE2905. 
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 342 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.
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