notyard
09-04-2008, 09:45 AM
FDA class II recall:
PRODUCT
a) ENDOPATH®ETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during
general, gynecologic, urologic, and thoracic surgery for transection, resection,
and/or creation of anastomoses, Recall # Z-2161-2008;
b) ENDOPATH®ETS Endoscopic Linear Cutter, TSW35. Utilized during general,
gynecologic, urologic, and thoracic surgery for transection, resection, and/or
creation of anastomoses, Recall # Z-2162-2008;
c) ENDOPATH®ETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W.
Utilized during general, gynecologic, urologic, and thoracic surgery for transection,
resection, and/or creation of anastomoses, Recall # Z-2163-2008;
d) 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, Recall # Z-2164-2008
CODE
a) 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;
b) 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;
c) 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;
d) 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
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letter on May 5, 2008.
Manufacturer: Ethicon Inc., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
VOLUME OF PRODUCT IN COMMERCE
42,434 pieces
DISTRIBUTION
Nationwide and Internationally
PRODUCT
a) ENDOPATH®ETS-Flex Endoscopic Linear Cutter, ATW35 Utilized during
general, gynecologic, urologic, and thoracic surgery for transection, resection,
and/or creation of anastomoses, Recall # Z-2161-2008;
b) ENDOPATH®ETS Endoscopic Linear Cutter, TSW35. Utilized during general,
gynecologic, urologic, and thoracic surgery for transection, resection, and/or
creation of anastomoses, Recall # Z-2162-2008;
c) ENDOPATH®ETS and ETS-Flex Endoscopic Linear Cutter Reload; TR35W.
Utilized during general, gynecologic, urologic, and thoracic surgery for transection,
resection, and/or creation of anastomoses, Recall # Z-2163-2008;
d) 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, Recall # Z-2164-2008
CODE
a) 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;
b) 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;
c) 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;
d) 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
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethicon Endo-Surgery Inc., Cincinnati, OH, by letter on May 5, 2008.
Manufacturer: Ethicon Inc., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
The firm discovered a component production issue which may cause the cartridge to deploy an incomplete staple line.
VOLUME OF PRODUCT IN COMMERCE
42,434 pieces
DISTRIBUTION
Nationwide and Internationally