Z-1108-2009

Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm, 20cc, Sterile EO, Bard...

Name: Z-1108-2009 Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm, 20cc, Sterile EO, Bard...
Creator: C R Bard Inc
Published: 2008-12-22
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2008-12-22 / Terminated / root cause: manufacturing process

FDA source

C R Bard Inc began a recall of Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A... on 2008-12-22. The reason FDA records is "Out of specification replacement gastrostomy device was distributed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1108-2009
Status: Terminated
Initiated: 2008-12-22
Posted: 2009-04-08
Terminated: 2010-05-18
Recalling firm: Bard Access Systems, Inc.
Product: Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm, 20cc, 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.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall: Out of specification replacement gastrostomy device was distributed.
Root cause tag: manufacturing process
FDA 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 in commerce: 221 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.
Product codes and lots: Lot numbers: HUSA0435, HUSD0286, HUSD2000, HUSH1659 and HUSI2766.

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)