Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00204W, 20F, 1.7cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.
FDA Recall Z-0420-2009 · Posted 2008-12-12
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Recalling FirmC R Bard Inc
Recall StatusTerminated
Product CodeKNT
Date Initiated2008-09-23
Date Terminated2011-11-08
Product Quantity1212 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.
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