FDA · Medical device recall

ENDOPATHETS-Flex Endoscopic Linear Cutter… and 3 more products

Aug. 25, 2008

Date posted by the FDA: Aug. 25, 2008
Status: Terminated
Filed by: Ethicon Endo-Surgery Inc
Reason: The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
Distribution pattern: 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.

4 products in this recall

ENDOPATHETS-Flex Endoscopic Linear Cutter…

Product: ENDOPATHETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
Quantity: 16,053 Pieces
Codes and lots: Batch #s: D4G751, D4G753, D4G80W, D4G84U, D4G85N, D4G983, D4GA5T, D4GA5U, D4GD6D, D4GE7U, D4GE7V, D4GH0X, D4GH8E, D4GK3M, D4GL0U, D4GN0F, D4GN0G, D4GN1C, D4GN85, D4GN86, D4GP7U, D4GP7V, D4GT3X, D4GT3Y, D4GW1U, D4GW1V, D4GW2H, D4GW3G, D4GW8H, D4H037, D4H038, D4H07L, D4H07M, D4H213, D4H214, D4H546, D4H55J, D4H61E, D4H61F, D4H66D, D4H66E, D4H804, D4H806, D4H80W, D4H80X, D4H82E, D4H86F, D4H91Z, D4H97U, D4H98J, D4H98K, D4HA2X, D4HA54, D4HC1X, D4HC1Y, D4HC93, D4HC94, D4HD95, D4HD96, D4HE2D, D4HE2E, D4HF2F, D4HF2G, D4HG65, D4HG66, D4HJ0A, D4HJ8R, D4HJ9K, D4HK2G, D4HK4G, D4HL5M, D4HL6K, D4HM2L, D4HM2N, D4HM7W, D4HN1Y, D4HN1Z, D4HN5E, D4HR1L, D4HR1M, D4HT53, D4HT5K, D4HU3W, D4HU3X, D4HU79, D4HV1P, D4HV3C, D4HV3D, D4HW0G, D4HW1A, D4HY9R, D4HZ86, D4J14K, D4J198, D4J199, D4J91, D4JC0, and D4JC9P
Recall started: April 24, 2008
Device type: Cutter, Surgical
Root cause (FDA): Other
What the company told customers: 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.
Recall number: Z-2161-2008

ENDOPATHETS Endoscopic Linear Cutter…

Product: ENDOPATHETS Endoscopic Linear Cutter, TSW35. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
Quantity: 10,734 pieces
Codes and lots: Batch #s: D4G80V, D4G97P, D4G97R, D4GA09, D4GC96, D4GC97, D4GF6G, D4GH13, D4GH5J, D4GJ58, D4GK8C, D4GL2R, D4GN4E, D4GN99, D4GR13, D4GT54, D4GT6V, D4GT93, D4GT9Z, D4GV02, D4GV03, D4H03D, D4H03F, D4H042, D4H052, D4H053, D4H090, D4H091, D4H092, D4H441, D4H442, D4H50M, D4H58Z, D4H68R, D4H68T, D4H69Z, D4H99F, D4H99G, D4HC0R, D4HC1C, D4HE3E, D4HF3M, D4HG1D, D4HG1E, D4HH26, D4HJ3W, D4HJ3X, D4HK4P, D4HL73, D4HM13, D4HM15, D4HP2L, D4HP2M, D4HP6G, D4HP6J, D4HR98, D4HR9A, D4HV3A, D4HW7Y, D4HX1D, D4HY6J, D4HY98, D4HZ1M, D4HZ1N, D4J09J, D4J17L
Recall started: April 24, 2008
Device type: Cutter, Surgical
Root cause (FDA): Other
What the company told customers: 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.
Recall number: Z-2162-2008

ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload…

Product: ENDOPATHETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W. Utilized during general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses.
Quantity: 14,784 pieces
Codes and lots: Batch #s: D4G80E, D4G85W, D4G903, D4G94L, D4GA32, D4GD36, D4GE66, D4GH0T, D4GJ2K, D4GK3Y, D4GK9L, D4GM52, D4GM7U, D4GN6E, D4GP0J, D4GP4R, D4GP72, D4GR0X, D4GT2T, D4GV6T, D4GV87, D4GW38, D4GW9W, D4H070, D4H18C, D4H22G, D4H44D, D4H46J, D4H48L, D4H49L, D4H51F, D4H60R, D4H70P, D4H72W, D4H77M, D4H86J, D4H903, D4H930, D4HA5E, D4HC0M, D4HC72, D4HE2N, D4HG0T, D4HG35, D4HG6F, D4HG9G, D4HH5V, D4HH9D, D4HJ8K, D4HL4G, D4HM5L, D4HN53, D4HP27, D4HP58, D4HP9X, D4HR68, D4HT58, D4HU52, D4HW1L, D4HW24, D4HW7N, D4HX45, D4HX8P, D4HY1D, D4HY6U, D4HZ5K, D4J03R, D4J08F, D4J13C, D4J187, D4G51J, D4G56F, D4G69L, D4G725
Recall started: April 24, 2008
Device type: Cutter, Surgical
Root cause (FDA): Other
What the company told customers: 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.
Recall number: Z-2163-2008

FlexTray"Procedure Delivery System ENDOPATH…

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.
Quantity: 863 pieces
Codes and 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
Recall started: April 24, 2008
Device type: Cutter, Surgical
Root cause (FDA): Other
What the company told customers: 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.
Recall number: Z-2164-2008

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement reports, recall numbers Z-2161-2008, Z-2162-2008, Z-2163-2008, Z-2164-2008. The agency record governs; check it and the company before acting.

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