FDA Medical Device Recalls (openFDA)
C R Bard Inc: Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00202W, 16F x 2.4cm, 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.
- Recall number
- Z-1098-2009
- Recalling firm
- C R Bard Inc
- Product
- Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00202W, 16F x 2.4cm, 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.
- Status
- Terminated
- Initiated
- 2008-12-22
- Posted
- 2009-04-08
- Terminated
- 2010-05-18
- 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
- 1280 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, Italy, France, Switzerland, Spain and Germany, Australia, and Latin America.
- Lot, serial or model codes
- Lot numbers: HUSC0045, HUSC2106, HUSD0283, HUSD1987, HUSD1988, HUSE1556, HUSF1910, HUSF1911, HUSG0498, HUSG1089, HUSG1090, HUSH1622, HUSH1653, HUSI2701 and HUSI2751.
- 510(k) numbers
- ["K013144"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 3006260740
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28