Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00203W, 20F, 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.
FDA Recall Z-0419-2009 · Posted 2008-12-12
Advertisement
Recalling FirmC R Bard Inc
Recall StatusTerminated
Product CodeKNT
Date Initiated2008-09-23
Date Terminated2011-11-08
Product Quantity490 units
Reason for Recall
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
Firm 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.
Root Cause
Component design/selection
Distribution Pattern
Worldwide Distribution including US, Latin America and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement