Bard Access Systems, Inc., Gauderer Genie* II PEG (Percutaneous Endoscopic Gastrostomy) Safety System Ponsky "Pull" Placement Technique REF 000373, 20F, STERILE.
FDA Recall Z-2179-2009 · Posted 2009-09-15
Recalling FirmC.R. Bard Access Systems, Inc
Recall StatusTerminated
Product CodeKNT
Date Initiated2008-12-04
Date Terminated2011-11-09
Product Quantity177,614 units
Reason for Recall
Snare can detach in patient. The Polypectomy Snares and the Entake Peg System (which contain these snares) are being recalled because the looped portion of the snare can become detached and drop into the stomach or other internal canal during use, necessitating retrieval of the remaining piece.
Firm Action
Bard contacted all 1,883 worldwide customers who received the distributed suspect 467 product code lots, comprising 177, 614 units that were either not expired or were still available in the field. These will be returned by the customer to Bard Access Systems. 1-800-290-1689.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide, including USA, Belgium, Canada, Australia, and Japan.
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.