Recall Z-2164-2008
Ethicon Endo-Surgery Inc · initiated April 24, 2008
Product
FlexTray"Procedure Delivery System ENDOPATH; FBW67XL, FD064, FDB15, TGL45XL, XBB02B, XBB58S, XBB59S, XLB01B, XLB50S, XPD51S. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
Codes / lots: Batch #: D4GR6F, D4GR6P, D4GT7G, D4H14H; Product Code: FD064, Batch # D4G520; Product Code: FDB15, Batch # D4GD04; Product Code: TGL45XL, Batch # D4J493; Product Code: XBB02B, Batch # D4GK74, D4GU1T, D4HL3X, D4HL7C, D4HM4P, D4HM9D, D4JE0R; Product Code: XBB58S, Batch # D4G94G, D4GK69, D4GP93, D4GW31, D4HG6V, D4J204; Product Code: XBB59S, Batch # D4GA1K, D4GC1G, D4GD9U, D4GD7C, D4GX8R, D4HD17, D4HD6X, D4HE54, D4HM6G; Product Code: XLB01B, Batch # D4GD0R, D4GF8J, D4H593, D4HR87; Product Code: XLB50S, Batch # D4GK4X, D4GP94, D4GT3K, D4HF0V, D4J47E, D4JE8P; Product Code: XPD51S, Batch # D4GT7T, D4HF7M , D4J32T
Reason for recall
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
FDA-determined cause: Other
Action taken
Firm issued an Urgent: Device Recall notification instructing the user to not use products from these lot numbers. Examine their inventory immediately to determine if they have affected product on hand and remove them from inventory. Complete the Business Reply Form and fax it back. To return affected product, copy the BRF, place in box with your product, and affix the pre-printed UPS shipping label.
Details
- Recall number
- Z-2164-2008
- Initiated
- April 24, 2008
- Posted by FDA
- August 25, 2008
- Terminated
- April 3, 2012
- Product code
- FZT – Cutter, Surgical
- Quantity
- 863 pieces
- Distribution
- Worldwide Distribution --- including USA and countries of ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BRAZIL, CAYMAN ISLANDS, CANADA, CHILE, CHINA, COLOMBIA, CZECH REPUBLIC, EGYPT, EL SALVADOR, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LEBANON, MEXICO, PAKISTAN, POLAND, PORTUGAL, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE…
- Recalling firm
- Ethicon Endo-Surgery Inc, Cincinnati, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2161-2008 | ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic…The firm discovered a component production issue which may cause the cartridge to deploy an incomplete… | 04/24/2008Terminated |
| Z-2162-2008 | ENDOPATHETS Endoscopic Linear Cutter, TSW35. Utilized during general, gynecologic…The firm discovered a component production issue which may cause the cartridge to deploy an incomplete… | 04/24/2008Terminated |
| Z-2163-2008 | ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during…The firm discovered a component production issue which may cause the cartridge to deploy an incomplete… | 04/24/2008Terminated |