Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00201W, 16F x 1.7cm, 10cc, 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.
This recall has been terminated (originally issued April 8, 2009).
- Company
- C R Bard Inc
- Recall Initiated
- December 22, 2008
- Posted
- April 8, 2009
- Terminated
- May 18, 2010
- Recall Number
- Z-1097-2009
- Quantity
- 1231 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Out of specification replacement gastrostomy device was distributed.
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, Italy, France, Switzerland, Spain and Germany, Australia, and Latin America.
Lot / Code Info
Lot numbers: HUSA0398, HUSA1482, HUSA1483, HUSC0043, HUSC0044, HUSD0282, HUSD0327, HUSD1985, HUSD1986, HUSE1555, HUSF1909, HUSG0010, HUSG1088, HUSH1632, HUSH1652 and HUSI2750.
Root Cause
Process control
Action Taken
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.