Device Recall ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters

Model # CTS45  Lot # F4PD36, Exp Date Jul-2014; Lot # F4PD9U, Exp Date Jul-2014; Lot # F4PG0X, Exp Date Aug-2014; Lot #, F4PG42, Exp Date Aug-2014; Lot # F4PG92, Exp Date Aug-2014; Lot # F4PH1N, Exp Date Aug-2014; Lot # F4PH4N, Exp Date Aug-2014; Lot # F4PJ4U, Exp Date Aug-2014; Lot # F4PK4W, Exp Date Aug-2014; Lot # F4PM4R, Exp Date Sep-2014; Lot # F4PM61, Exp Date Sep-2014; Lot # F4PN2E, Exp Date Sep-2014; Lot # F4PN8Z, Exp Date Sep-2014; Lot # F4PP1A, Exp Date Sep-2014; Lot # F4PP9F, Exp Date Sep-2014; Lot # F4PR1V, Exp Date Sep-2014; Lot # F4PU0Y, Exp Date Sep-2014; Lot # F4PU6Y, Exp Date Sep-2014; Lot # F4PV1E, Exp Date Oct-2014; Lot # F4PW2Z, Exp Date Oct-2014; Lot # F4PX14, Exp Date Oct-2014; Lot # F4PX5J, Exp Date Oct-2014; Lot # F4PX81, Exp Date Oct-2014; Lot # F4PY36, Exp Date Oct-2014; Lot # F4PY9W, Exp Date Oct-2014; Lot # F4PZ7L, Exp Date Oct-2014; Lot # F4PZ9H, Exp Date Oct-2014; Lot # F4R11D, Exp Date Nov-2014; Lot # F4R14L, Exp Date Nov-2014; Lot # F4R172, Exp Date Nov-2014; Lot # F4R213, Exp Date Nov-2014; Lot # F4R299, Exp Date Nov-2014; Lot # F4R31F, Exp Date Nov-2014; Lot # F4R435, Exp Date Nov-2014; Lot # F4R45U, Exp Date Nov-2014; Lot # G4R54T, Exp Date Dec-2014; Lot # G4R81J, Exp Date Dec-2014; Lot # G4R823, Exp Date Dec-2014; Lot # G4R971, Exp Date Dec-2014; Lot # G4R97A, Exp Date Dec-2014; Lot # G4R99A, Exp Date Dec-2014; Lot # G4RD0H, Exp Date Jan-2015; Lot # G4RD6P, Exp Date Jan-2015; Lot # G4RE6K, Exp Date Jan-2015; Lot # G4RG45, Exp Date Jan-2015; Lot # G4RG7C, Exp Date Jan-2015; Lot # G4RH07, Exp Date Jan-2015; Lot # G4RH1E, Exp Date Jan-2015; Lot # G4RL49, Exp Date Feb-2015; Lot # G4RM0M, Exp Date Feb-2015; Lot # G4RN6U, Exp Date Feb-2015; Lot # G4RN81, Exp Date Feb-2015; Lot # G4RP03, Exp Date Feb-2015; Lot # G4RP4M, Exp Date Feb-2015; Lot # G4RP8C, Exp Date Feb-2015; Lot # G4RR9N, Exp Date Feb-2015; Lot # G4RT2F, Exp Date Feb-2015; Lot # G4RT7H, Exp Date Feb-2015; Lot # G4RU9U, Exp Date Mar-2015; Lot # G4RV45, Exp Date Mar-2015; Lot # G4RV6G, Exp Date Mar-2015; Lot # G4RV95, Exp Date Mar-2015; Lot # G4RW0J, Exp Date Mar-2015; Lot # G4RX6X, Exp Date Mar-2015; Lot # G4RY1G, Exp Date Mar-2015; Lot # G4RY2D, Exp Date Mar-2015; Lot # G4RY4N, Exp Date Mar-2015; Lot # G4RZ1U, Exp Date Mar-2015; Lot # G4T04U, Exp Date Apr-2015; Lot # G4T099, Exp Date Apr-2015; Lot # G4T12L, Exp Date Apr-2015; Lot # G4T159, Exp Date Apr-2015; Lot # G4T39L, Exp Date Apr-2015; Lot # G4T43Y, Exp Date Apr-2015; Lot # G4T48N, Exp Date Apr-2015; Lot # G4T553, Exp Date Apr-2015; Lot # G4T59H, Exp Date Apr-2015; Lot # G4T86K, Exp Date May-2015; Lot # G4T92W, Exp Date May-2015; Lot # G4T96N, Exp Date May-2015; Lot # G4TA3E, Exp Date May-2015; Lot # G4TC5W, Exp Date May-2015; Lot # G4TC82, Exp Date May-2015; Lot # G4TE91, Exp Date Jun-2015; Lot # G4TG0U, Exp Date Jun-2015; Lot # G4TK3C, Exp Date Jun-2015; Lot # G4TK5X, Exp Date Jun-2015; Lot # G4TL66, Exp Date Jul-2015; Lot # G4TL6N, Exp Date Jul-2015; Lot # G4TM1L, Exp Date Jul-2015; Lot # G4TN19, Exp Date Jul-2015; Lot # G4TN5F, Exp Date Jul-2015; Lot # G4TP0Y, Exp Date Jul-2015; Lot # G4TP51, Exp Date Jul-2015; Lot # G4TP88, Exp Date Jul-2015; Lot # G4TR5K, Exp Date Jul-2015 Lot # G4TR9T, Exp Date Jul-2015; Lot # G4TT8Z, Exp Date Jul-2015; Lot # G4TU1G, Exp Date Aug-2015; Lot # G4TU1J, Exp Date Aug-2015; Lot # G4TV44, Exp Date Aug-2015; Lot # G4TX08, Exp Date Aug-2015; Lot # G4TX3H, Exp Date Aug-2015; Lot # G4TZ93, Exp Date Aug-2015; Lot # G4U020, Exp Date Aug-2015; Lot # G4U10D, Exp Date Sep-2015; Lot # G4U13F, Exp Date Sep-2015; Lot # G4U19A, Exp Date Sep-2015; Lot # G4U22Z, Exp Date Sep-2015; Lot # G4U28H, Exp Date Sep-2015; Lot # G4U51C, Exp Date Sep-2015; Lot # G4U62P, Exp Date Sep-2015; Lot # G4U62V, Exp Date Sep-2015; Lot # G4U83X, Exp Date Oct-2015; Lot # G4U91N, Exp Date Oct-2015; Lot # G4U94C, Exp Date Oct-2015; Lot # G4UA7G, Exp Date Oct-2015; Lot # G4UC07, Exp Date Oct-2015; Lot # G4UC4D, Exp Date Oct-2015; Lot # G4UC88, Exp Date Oct-2015; Lot # G4UD43, Exp Date Oct-2015; Lot # G4UD5C, Exp Date Oct-2015; Lot # G4UG3F, Exp Date Nov-2015; Lot # G4UG3J, Exp Date Nov-2015; Lot # G4UG82, Exp Date Nov-2015; Lot # G4UH9L, Exp Date Nov-2015; Lot # H4315X, Exp Date Dec-2015; Lot # H4317R, Exp Date Dec-2015; Lot # H4320H, Exp Date Dec-2015; Lot # H43303, Exp Date Dec-2015; Lot # H43369, Exp Date Dec-2015; Lot # H43409, Exp Date Dec-2015; Lot # H43436, Exp Date Dec-2015; Lot # H4351F, Exp Date Dec-2015; Lot # H43914, Exp Date Jan-2016; Lot # H43966, Exp Date Jan-2016; Lot # H43985, Exp Date Jan-2016; Lot # H43A2A, Exp Date Jan-2016; Lot # H43A4W, Exp Date Jan-2016; Lot # H43C68, Exp Date Jan-2016; Lot # H43E38, Exp DateFeb-2016; Lot # H43F4A, Exp Date Feb-2016; Lot # H43F6N, Exp Date Feb-2016; Lot # H43H3M, Exp Date Feb-2016; Lot # H43H64, Exp Date Feb-2016; Lot # H43H8J, Exp Date Feb-2016; Lot # H43J4N, Exp Date Feb-2016; Lot # H43M40, Exp Date Mar-2016; Lot # H43N4D, Exp Date Mar-2016; Lot # H43N5P, Exp Date Mar-2016; Lot # H43P11, Exp Date Mar-2016; Lot # H43R8Y, Exp Date Apr-2016; Lot # H43T5E, Exp Date Apr-2016; Lot # H43U8W, Exp Date Apr-2016; Lot # H43V5H, Exp Date Apr-2016; Lot # H43W06, Exp Date Apr-2016; Lot # H43W6C, Exp Date Apr-2016; Lot # H4402J, Exp Date May-2016; Lot # H4404X, Exp Date May-2016; Lot # H44303, Exp Date May-2016; Lot # H44369, Exp Date Jun-2016; Lot # H44604, Exp Date Jun-2016 and Lot # H4465K, Exp Date Jun-2016.   Model # CTS45NK  Lot # G4TZ37, Exp Date Aug-2015; Lot # G4UC08, Exp Date Oct-2015; Lot # H43A10, Exp Date Jan-2016 and Lot # H43W25, Exp Date Apr-2016.  Model # 6CB45  Lot # F4PE3Z, Exp Date Aug-2014; Lot # F4PH99, Exp Date Aug-2014; Lot # F4PR04, Exp Date Sep-2014; Lot # F4PX54, Exp Date Oct-2014; Lot # F4R204, Exp Date Nov-2014; Lot # G4R554, Exp Date Dec-2014; Lot # G4RD0F, Exp Date Jan-2015; Lot # G4RF4W, Exp Date Jan-2015; Lot # G4RJ23, Exp Date Jan-2015; Lot # G4RJ4D, Exp Date Jan-2015; Lot # G4RM6R, Exp Date Feb-2015; Lot # G4RR8N, Exp Date Feb-2015; Lot # G4RT26, Exp Date Feb-2015; Lot # G4RV11, Exp Date Mar-2015; Lot # G4RW1U, Exp Date Mar-2015; Lot # G4TJ4J, Exp Date Jun-2015; Lot # G4TN2N, Exp Date Jul-2015; Lot # G4TV1Z, Exp Date Aug-2015; Lot # G4UA7F, Exp Date Oct-2015; Lot # G4UC4C, Exp Date Oct-2015; Lot # H4345P, Exp Date Dec-2015 and Lot # H43L03, Exp Date Mar-2016.  Model # SCB45  Lot # F4PE3E, Exp Date Aug-2014; Lot # F4PL2N, Exp Date Aug-2014; Lot # F4PL31, Exp Date Sep-2014; Lot # F4PU2W, Exp Date Sep-2014 and Lot # F4PV36, Exp Date Oct-2014.  Model # SCG45  Lot # F4PL3M, Exp Date Sep-2014; Lot # F4PU2X, Exp Date Sep-2014; Lot # F4PX78, Exp Date Oct-2014; Lot # G4R72N, Exp Date Dec-2014; Lot # G4RC02, Exp Date Dec-2014; Lot # G4RJ3X, Exp Date Jan-2015; Lot # G4RL3U, Exp Date Feb-2015; Lot # G4RW9M, Exp Date Mar-2015; Lot # G4TC56, Exp Date May-2015; Lot # G4TR5C, Exp Date Jul-2015; Lot # G4UD5R, Exp Date Oct-2015; Lot # H43753, Exp Date Jan-2016; Lot # H43E0M, Exp Date Feb-2016 and Lot # H43L83, Exp Date Mar-2016.  Model # SCW45  Lot # F4PD3H, Exp Date Jul-2014; Lot # F4PE5V, Exp Date Aug-2014; Lot # F4PF5T, Exp Date Aug-2014; Lot # F4PL3P, Exp Date Sep-2014; Lot # F4PM1H, Exp Date Sep-2014; Lot # F4PU40, Exp Date Sep-2014; Lot # F4PV44, Exp Date Oct-2014; Lot # F4PW81, Exp Date Oct-2014; Lot # F4R15T, Exp Date Nov-2014; Lot # F4R27D, Exp Date Nov-2014; Lot # F4R352, Exp Date Nov-2014; Lot # G4R69T, Exp Date Dec-2014; Lot # G4R809, Exp Date Dec-2014; Lot # G4RC03, Exp Date Dec-2014; Lot # G4RF2X, Exp Date Jan-2015; Lot # G4RJ4K, Exp Date Jan-2015; Lot # G4RL44, Exp Date Feb-2015; Lot # G4RM75, Exp Date Feb-2015; Lot # G4RP7N, Exp Date Feb-2015; Lot # G4RU54, Exp Date Mar-2015; Lot # G4RX1E, Exp Date Mar-2015; Lot # G4RX62, Exp Date Mar-2015; Lot # G4T14R, Exp Date Apr-2015; Lot # G4T63F, Exp Date Apr-2015; Lot # G4TA7E, Exp Date May-2015; Lot # G4TF2K, Exp Date Jun-2015; Lot # G4TM93, Exp Date Jul-2015; Lot # G4TX42, Exp Date Aug-2015; Lot # G4U04J, Exp Date Sep-2015; Lot # G4U164, Exp Date Sep-2015; Lot # G4U74G, Exp Date Oct-2015; Lot # G4UA6K, Exp Date Oct-2015; Lot # H4305X, Exp Date Dec-2015; Lot # H4324F, Exp Date Dec-2015; Lot # H4329P, Exp Date Dec-2015; Lot # H43755, Exp Date Jan-2016; Lot # H43C2U, Exp Date Jan-2016; Lot # H43H0K, Exp Date Feb-2016; Lot # H43M8E, Exp Date Mar-2016; Lot # H43R6T, Exp Date Apr-2016 and Lot # H4406Z, Exp Date May-2016.

General and Plastic Surgery Devices

2

Yes

Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI and WV and the countries of ARGENTINA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, CHINA, CZECH REPUBLIC, GREECE, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LIBYAN ARAB JAMAHIRIYA, MALAYSIA, MEXICO, POLAND, PUERTO RICO, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, THAILAND and UNITED ARAB EMIRATES

ENDOPATH¿ ETS Compact Flex (240 mm shaft length) Linear Cutters, Model Number(s): SCW45; CTS45; SCB45; CTS45NK; 6CB45 and SCG45. Mfr. By: Ethicon Endo-Surgery, LLC, Guaynabo, PR 00969 || The ETS Compact-Flex45 Articulating Linear Cutter is intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.