Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00202W, 16F, 2.4cm, 10cc, Sterile EO, Bard Access Syst
FDA device recall Z-0418-2009 · posted 2008-12-12 · Terminated
Recall details
- Recalling firm
- C R Bard Inc
- Reason for recall
- Gastrostomy device anti-reflux valve may allow leakage from the stomach.
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 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.
- Date initiated
- 2008-09-23
- Date posted
- 2008-12-12
- Date terminated
- 2011-11-08
- Location
- Salt Lake City, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE; DUAL PORT WIZARD FEEDING/DECOMPRESSION TUBE, MODEL 00220W (K013144) | C.R. Bard, Inc. | 2001-10-19 |