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U.S. Department of Health and Human Services

Class 2 Device Recall Enteral feeding replacement device.

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  Class 2 Device Recall Enteral feeding replacement device. see related information
Date Initiated by Firm December 22, 2008
Date Posted April 08, 2009
Recall Status1 Terminated 3 on May 18, 2010
Recall Number Z-1114-2009
Recall Event ID 50696
510(K)Number K013144  
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
Product Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00222W, 18F x 1.7cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.

A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
Code Information Lot numbers: HUSA0454, HUSA0455, HUSA1490, HUSC0128, HUSD0345, HUSD0346, HUSD2009, HUSD2010, HUSE1570, HUSE1571, HUSF1923, HUSF1924, HUSG1116, HUSG1117, HUSH1297, HUSH1627, HUSH1666, HUSI2769 and HUSI2770.
Recalling Firm/
Manufacturer		 C R Bard Inc
605 N 5600 W
Salt Lake City UT 84116-3738
For Additional Information Contact
801-596-5432
Manufacturer Reason
for Recall		 Out of specification replacement gastrostomy device was distributed.
FDA Determined
Cause 2		 Process control
Action Consignees were notified by "Product Recall" letter distributed on January 7, 2009 via Federal Express overnight mail and asked to check all inventory locations, remove unused affected product and return to Bard Access Systems, Inc (BAS). Customers were also instructed to complete the enclosed Reply Form and Inventory Reconciliation Form and fax it to BAS at 1-801-522-5674. Additional information is available by calling BAS Customer Service at 1-800-290-1689.
Quantity in Commerce 475 units
Distribution Worldwide Distribution, USA (states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, NH, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV) and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, United Kingdom, Italy, France, Switzerland, Spain and Germany, Australia, and Latin America.
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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