—#73880

Product

Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00216W, 24F, 1.7cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.

FDA product code: KNT — Tubes, Gastrointestinal (And Accessories)
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K013144
Affected lot / code info: 43AOA025, 43BOA024, 43BOA042, 43BQA009, 43BQA050, 43COA021, 43COA042, 43CQA026, 43DOA023, 43DPA024, 43DPA217, 43DQA019, 43DQA069, 43EOA025, 43EPA022, 43EQA019, 43FOA091, 43FOA120, 43FPA180, 43FQA008, 43GOA019, 43GOA039, 43GPA153, 43GPA176R, 43GPA191R, 43GPA215R, 43GPA216R, 43GPA217R, 43GPA239R, 43GQA012, 43HOA040, 43HPA028, 43HPA059, 43HPA219, 43INA018, 43INA045, 43IOA049, 43IPA026, 43IPA051, 43IPA205R, 43IQA015, 43JOA026, 43JPA022, 43JPA046, 43JQA008, 43KNA019, 43KNA061, 43KOA025, 43KPA020, 43KQA008, 43LNA028, 43LNA059, 43LOA037, 43LPA011, 43LQA009, HURB2435, HURD0683, HURD1931, HURE2909, HURH1096, HURJ0612, HURJ1595, HURK1516, HURA1341, HURD1930, HURG1457, HURI0867, and HURJ0611.

Why it was recalled

Gastrostomy device anti-reflux valve may allow leakage from the stomach.

Root cause (FDA determination)

Component design/selection

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution including US, Latin America and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany.

Timeline

Recall initiated: 2008-09-23
Posted by FDA: 2008-12-12
Terminated: 2011-11-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73880. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.