Z-0417-2009

Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F, 1.7cm, 10cc, Sterile EO, Bard...

Name: Z-0417-2009 Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F, 1.7cm, 10cc, Sterile EO, Bard...
Creator: C R Bard Inc
Published: 2008-09-23
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2008-09-23 / Terminated / root cause: design

FDA source

C R Bard Inc began a recall of 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... on 2008-09-23. The reason FDA records is "Gastrostomy device anti-reflux valve may allow leakage from the stomach". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0417-2009
Status: Terminated
Initiated: 2008-09-23
Posted: 2008-12-12
Terminated: 2011-11-08
Recalling firm: Bard Access Systems, Inc.
Product: 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.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: Gastrostomy device anti-reflux valve may allow leakage from the stomach.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 1881 units
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.
Product codes and lots: 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.

Product code KNT

K013144Class IIDual Port Wizard Low Profile Replacement Gastrostomy Device; Dual Port Wizard Feeding/decompression Tube, Model 00220WC.R. Bard, Inc. / cleared 2001-10-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)