Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F, 1.7cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. Dual Port Wizard Low Profile Replacement Gastrostomy Device is a silicone low-profile balloon-type device designed for percutaneous insertion through an established, appropriately sized stoma tract. The Dual Port Wizard Device is packaged in a kit which also includes two tubes, two gauze pads, and a syringe. The Wizard anti-reflux valve is a component of the Dual Port Wizard Gastrostomy Device. The inserted device is used for enteral feeding.
This recall has been terminated (originally issued December 12, 2008).
- Company
- C R Bard Inc
- Recall Initiated
- September 23, 2008
- Posted
- December 12, 2008
- Terminated
- November 8, 2011
- Recall Number
- Z-0417-2009
- Quantity
- 1881 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
Distribution
Worldwide Distribution including US, Latin America and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, Great Britain, Italy, France, Switzerland, Spain, Germany.
Lot / Code Info
43AOA019, 43LNA053, 43AOA042, 43LOA024, 43APA033, 43LPA008, 43ARAOO2, 43LQAO29, HURA1265, 43BOA016, HURB2526, 43BOA038, HURB4356, 43BQA043, HURB4357, 43COA014, HURD1917, 43COA037, HURF0484, 43DOA011, HURG1445, HURH1079, HURJ0002, 43DOA038, 43DOA203, 43DPA015, HURJ0595, 43DPA044, HURJ1549, 43DPA204, HURK1491, 43DPA205, HURB2425, 43DQA064, HURB4421, 43EOA014, HURD1916, 43EOA042, HURE2890, 43EPA014, HURF0485, 43EPAO41, HURH0242, 43EPA209, HURH1080, 43EPA216, HURJ1557, 43EQA009, 43FOA077, 43FOA108, 43GOA034, 43GPA179R, 43GPA180R, 43GQA001, 43GQA032, 43HPA019R, 43HPA192, 43HPA225R, 43HQA001, 43HQA165, 43INA032, 43IOA039, 43IPAO18, 43IPA041, 43IPA199R, 43IQA002, 43JNA002, 43JNA045, 43JNA204, 43JOA015, 43JPA014, 43JPA037, 43JQA001, 43JQA027, 43KPA014, 43KQA001, 43KQA027, and 43LNA023.
Root Cause
Component design/selection
Action Taken
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.