—#76302

Product

Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00224W, 18F x 3.4cm, 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.

FDA product code: KNT — Tubes, Gastrointestinal (And Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K013144
Affected lot / code info: Lot numbers: HUSA0458, HUSA0459, HUSC0131, HUSC1295, HUSD0348, HUSD0349, HUSD2013, HUSD2014, HUSE0894, HUSE1574, HUSF1925, HUSF1926, HUSG1120, HUSH1629, HUSH1668, HUSI2711 and HUSI2773.

Why it was recalled

Out of specification replacement gastrostomy device was distributed.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: C R Bard Inc
Address: 605 N 5600 W, Salt Lake City, Utah 84116-3738

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-12-22
Posted by FDA: 2009-04-08
Terminated: 2010-05-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #76302. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.