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.
This recall has been terminated (originally issued August 25, 2008).
- Company
- Ethicon Endo-Surgery Inc
- Recall Initiated
- April 24, 2008
- Posted
- August 25, 2008
- Terminated
- April 3, 2012
- Recall Number
- Z-2164-2008
- Quantity
- 863 pieces
- Firm Location
- Cincinnati, OH
- Official Source
- View on FDA website ↗
Reason for Recall
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
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, SLOVENIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM & VENEZULA.
Lot / Code Info
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
Root 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.