Recall Z-2204-2009 ยท KNT Tubes, Gastrointestinal (And Accessories)
C.R. Bard Access Systems, Inc
Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 003029, 20F, Sterile.
| Date | Sep 15, 2009 (initiated Dec 4, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| 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. |
| Quantity | 177,614 units |
| Distribution | Worldwide, including USA, Belgium, Canada, Australia, and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033562 | FASTRAC GASTRIC ACCESS PORT KIT C.R. Bard, Inc., Dec 12, 2003 |
| K061021 | ENTAKE STANDARD AND SAFETY PEG SYSTEM Conmedcorp, Apr 28, 2006 |
| K915841 | BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC C.R. Bard, Inc., Jun 25, 1993 |
| K972025 | RADIUS PULL PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KIT Radius Intl., Inc., Jan 23, 1998 |
| K972101 | SOLITAIRE Heraeus Kulzer, Inc., Sep 29, 1997 |