Recall Z-0416-2009 ยท KNT Tubes, Gastrointestinal (And Accessories)
C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00200W, 16F, 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
| Date | Dec 12, 2008 (initiated Sep 23, 2008) |
| Status | Terminated |
| Reason | Gastrostomy device anti-reflux valve may allow leakage from the stomach. |
| Root cause | Component design/selection |
| 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. |
| Quantity | 1167 units |
| Distribution | Worldwide Distribution including US, Latin America and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013144 | DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W C.R. Bard, Inc., Oct 19, 2001 |