Recall Z-0418-2009
C R Bard Inc · initiated September 23, 2008
Product
Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00202W, 16F, 2.4cm, 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.
Codes / lots: 43AOA020, 43AOA012, 43APA014, 43JQA028, 43APA034, 43KNA054, 43KPA015, 43ARA030, 43KQA028, 43BOA017, 43LNA024, 43BPA010, 43LNA054, 43BQA007, 43LOA009, 43BQA044, 43LOA025, 43COA015, 43LPA112, 43CPA014, 43LQA003, 43CQA015, 43LQA030, 43CQA234, HURA1274, HURB2527, 43DOA012, HURB4359, 43DPA016, HURB4563, 43DPA045, HURD1919, 43DPA206, HURE2891, 43DQA009, HURF0487, 43EOA015, HURG1446, 43EOA043, HURH1082, 43EPAO15, HURJ0005, 43EPA042, 43EPA217, HURJ0597, 43EQA010, HURCA095, 43FOA078, HURE2892, 43FOA109, HURF0486, 43FOA229, HURG1447, 43FQA001, HURH1081, 43GOA011, HURJ0598, 43GPA147, HURJ1559, 43GPA148, 43GPA196R, 43GPA230R, 43GPA231R, 43GQA002, 43GQA033, 43HOA033, 43HPA020, 43HPA051, 43HQA002, 43HQA155, 43HQA163, 43IOA013, 43IOA040, 43IPA019, 43IPA212, 43IPA213, 43IQA003, 43JNA003, 43JOA016, 43JPA015, 43JPA193, and 43JQA002.
Reason for recall
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
FDA-determined 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.
Details
- Recall number
- Z-0418-2009
- Initiated
- September 23, 2008
- Posted by FDA
- December 12, 2008
- Terminated
- November 8, 2011
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Quantity
- 1399 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.
- Recalling firm
- C R Bard Inc, Salt Lake City, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0416-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00200W, 16F, 1.2cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0417-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00201W, 16F, 1.7cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0419-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00203W, 20F, 1.2cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0420-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00204W, 20F, 1.7cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0421-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00205W, 20F, 2.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0422-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00206W, 20F, 3.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0423-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00207W, 20F, 4.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0424-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00209W, 16F, 1.7cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0425-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00210W, 16F, 2.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0426-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00212W, 20F, 1.7cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0427-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00213W, 20F, 2.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0428-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00214W, 20F, 3.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0429-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00215W, 20F, 4.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0430-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00216W, 24F, 1.7cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0431-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00217W, 24F, 2.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0432-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00218W, 24F, 3.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0433-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00219W, 24F, 4.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0434-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00221W, 18F, 1.2cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0435-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00222W, 18F, 1.7cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0436-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00223W, 18F, 2.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0437-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00224W, 18F, 3.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |
| Z-0438-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00225W, 18F, 4.4cm…Gastrostomy device anti-reflux valve may allow leakage from the stomach. | 09/23/2008Terminated |