Recall Z-1103-2009
C R Bard Inc · initiated December 22, 2008
Product
Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00207W, 20F x 4.4cm, 10cc, 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.
Codes / lots: Lot numbers: HUSA0411, HUSA0412, HUSC0040, HUSD0334, HUSD0335, HUSD1910, HUSD1997, HUSE1563, HUSF1284, HUSF1915, HUSG1105, HUSH1604 and HUSI2761.
Reason for recall
Out of specification replacement gastrostomy device was distributed.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1103-2009
- Initiated
- December 22, 2008
- Posted by FDA
- April 8, 2009
- Terminated
- May 18, 2010
- Product code
- KNT – Tubes, Gastrointestinal (And Accessories)
- Quantity
- 2254 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.
- Recalling firm
- C R Bard Inc, Salt Lake City, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1096-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00200W, 16F x 1.2cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1097-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00201W, 16F x 1.7cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1098-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00202W, 16F x 2.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1099-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00203W, 20F x 1.2cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1100-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00204W, 20F x 1.7cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1101-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00205W, 20F x 2.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1102-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00206W, 20F x 3.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1104-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00210, 16F x 2.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1105-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00212W, 20F x 1.7cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1106-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00213W, 20F x 2.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1107-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00214W, 20F x 3.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1108-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1109-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00216W, 24F x 1.7cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1110-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00217W, 24F x 2.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1111-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00218W, 24F x 3.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1112-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00219W, 24F x 4.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1113-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00221W, 18F x 1.2cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1114-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00222W, 18F x 1.7cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1115-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00223W, 18F x 2.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1116-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00224W, 18F x 3.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |
| Z-1117-2009 | Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00225W, 18F x 4.4cm…Out of specification replacement gastrostomy device was distributed. | 12/22/2008Terminated |