Recall Z-1108-2009 ยท KNT Tubes, Gastrointestinal (And Accessories)
C R Bard Inc
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device.
| Date | Apr 8, 2009 (initiated Dec 22, 2008) |
| Status | Terminated |
| Reason | Out of specification replacement gastrostomy device was distributed. |
| Root cause | Process control |
| Action | Consignees were notified by "Product Recall" letter distributed on January 7, 2009 via Federal Express overnight mail and asked to check all inventory locations, remove unused affected product and return to Bard Access Systems, Inc (BAS). Customers were also instructed to complete the enclosed Reply Form and Inventory Reconciliation Form and fax it to BAS at 1-801-522-5674. Additional information is available by calling BAS Customer Service at 1-800-290-1689. |
| Quantity | 221 units |
| Distribution | Worldwide Distribution, USA (states of AL, AZ, CA, CO, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MD, MI, MN, MO, MS, NC, NH, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV) and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, United Kingdom, |
| 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 |