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U.S. Department of Health and Human Services

Class 2 Device Recall ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters

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 Class 2 Recall
ENDOPATH ETS Compact Flex (240 mm shaft length) Linear Cutters
see related information
Date Posted September 12, 2011
Recall Status1 Terminated on February 15, 2013
Recall Number Z-3187-2011
Recall Event ID 59764
Premarket Notification
510(K) Numbers
K020779  K061156  K070887 
Product Classification Staple, Implantable - Product Code GDW
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati, Ohio 45242-2803
For Additional Information Contact Thomas A. Morris
513-337-3419
Manufacturer Reason
for Recall
Ethicon Endo-Surgery initiated a voluntary global recall for specific production lots of ENDOPATH¿ ETS Compact Flex 45mm articulating linear cutters because the possibility exists that damage to the blister pack may have compromised the sterility of the device.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging
Action Ethicon Endo-Surgery Inc sent an URGENT DEVICE RECALL letter dated August 11, 2011 to all affected customers. The letter identified the product, the problem, the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have any of the affected product. Fill out the Business Reply Form and fax it to 1-866-853-2802 if they have any of the affected product. To ensure adequate identification of the return product at their facility customers should complete the Customer Purchase Order Field on the Business Reply Form. For any questions regarding this recall call 1-866-708-2330 and reference Event 2471. For clinical or product support call 1-800-USE-ENDO, option 6, or contact your local sales representative.
Quantity in Commerce 27,582 instruments
Distribution 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = ETHICON ENDO-SURGERY, INC.
510(K)s with Product Code = GDW and Original Applicant = ETHICON ENDO-SURGERY, LLC
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