Recall Z-1124-2008
Ev3, Inc · initiated January 18, 2008
Product
ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-16, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-1431-000. ev3 IntraStent LD DoubleStrut Large Diameter Peripheral Stent, Model Number: S15-16, Catalog Number: 90-1504-000 (not approved within USA).
Codes / lots: Lot Numbers: 2767839, 2715678, and 2790795
Reason for recall
Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the two symbols for length and diameter on the side and end flaps reversed.
FDA-determined cause: Labeling Change Control
Action taken
ev3 notified all consignees via "Medical Device Recall" letter on 1/18/08. The letter was addressed to the Hospital and it described the device affected and the problem. The letter provided recommendations to segregate the affected devices and requested the return of the "Device Recall Field Action Reconciliation Form."
Details
- Recall number
- Z-1124-2008
- Initiated
- January 18, 2008
- Posted by FDA
- May 6, 2008
- Terminated
- November 4, 2008
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- Quantity
- 22
- Distribution
- Worldwide Distribution - USA, ARGENTINA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, DENMARK, GERMANY, GREECE, HONG KONG, IRAN, IRELAND, ITALY, JORDAN, KUWAIT, LEBANON, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
- Recalling firm
- Ev3, Inc, Plymouth, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1120-2008 | ev3 IntraStent Biliary Stent, Model Number: S10-26, ev3, 4600 Nathan Lane North…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1121-2008 | ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16, ev3, 4600 Nathan Lane…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1122-2008 | ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26, ev3, 4600 Nathan Lane…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1123-2008 | ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36, ev3, 4600 Nathan Lane…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1125-2008 | ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36, ev3…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1126-2008 | ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-16, ev3, 4600…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1127-2008 | ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26, ev3, 4600…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1128-2008 | ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36, ev3, 4600…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1129-2008 | ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16, ev3, 4600…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1130-2008 | ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, ev3, 4600…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |
| Z-1131-2008 | ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-36, ev3, 4600…Incorrect information on label: Specific lots of ev3 IntraStent Unmounted Balloon Expandable Stents have the… | 01/18/2008Terminated |