Dual Port Wizard Low Profile Replacement Gastrostomy Device, Code 00222W, 18F, 1.7cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116.
This recall has been terminated (originally issued December 12, 2008).
- Company
- C R Bard Inc
- Recall Initiated
- September 23, 2008
- Posted
- December 12, 2008
- Terminated
- November 8, 2011
- Recall Number
- Z-0435-2009
- Quantity
- 690 units
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Gastrostomy device anti-reflux valve may allow leakage from the stomach.
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 / Code Info
43APA018, 43BPA033, 43BQA053, 43CPA025, 43DPA028, 43DPA053, 43FPA181, 43GPA158, 43GPA159, 43HPA062, 43HPA233R, 43HQA036, 43INA049, 43IOA053, 43JNA052, 43JOA031, 43JPA050, 43KNA066, 43KOA029, 43KPA061, 43KQA044, 43LOA041, 43LPA043, 43LQA046, HURA1348,HURE3351, HURF0511, and HURJ0895.
Root 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.