FDA Medical Device Recalls (openFDA)
C R Bard Inc: Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00204W, 20F, 1.7cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.
- Recall number
- Z-0420-2009
- Recalling firm
- C R Bard Inc
- Product
- Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00204W, 20F, 1.7cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.
- Status
- Terminated
- Initiated
- 2008-09-23
- Posted
- 2008-12-12
- Terminated
- 2011-11-08
- Reason
- Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- 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
- 1212 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.
- Lot, serial or model codes
- 43APA035, 43ARA005, 43BOA039, 43BQA008, 43BQA046, 43COA017, 43COA039, 43CQA017, 43CQA236, 43DOA014, 43DPA208, 43DPA209, 43DQA011, 43EOA017, 43EOA045, 43EPA017, 43EPA044, 43EPA210, 43FOA080, 43FOA111, 43FQA002, 43GPA174R, 43GPA175R, 43GPA192R, 43GQA003, 43HOA034, 43HPA021R, 43HPA053R, 43HQA004, 43INA014, 43IOA041, 43IPA021R, 43IPA043R, 43IQA004, 43JNA004, 43JNAO47, 43JNA206, 43JOA018, 43JPA017, 43JPA038, 43JQA003, 43KNA015, 43KOA017, 43KPA016, 43KPA056, 43KQA003, 43KQA030, 43LNA055, 43LOA027, 43LPA009, 43LPA039, 43LQA005, 43LQA032, HURB3524, HURB4420, HURD1921, HURG1448, HURH1084, HURJ0602, HURK1510, HURB2428, HURD0505, HURE2896, and HURJ0601.
- 510(k) numbers
- ["K013144"]
- PMA numbers
- not on file
- Product code
- KNT
- Firm FEI
- 3006260740
- Firm city
- Salt Lake City
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28