Class 2 Device Recall LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code ER320)

• Date Initiated by Firm: June 07, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on October 29, 2008
• Recall Number: Z-1055-04
• Recall Event ID: 29269
• 510(K)Number: K864102
• Product Classification: Applier, Surgical, Clip - Product Code GDO
• Product: LIGACLIP ERCA Endoscopic Rotating Multiple Clip Applier (Product Code: ER320) and assorted Flex Trays(Convenience Kits), containing ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers.
• Code Information: Multiple lot codes of Model ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers and multiple varieties and Lot Numbers of Flex Trays incorporating the clip appliers are subject to recall. The recalled codes represent all ER320 LIGACLIPS and/or kits containing ER320 LIGACLIPS, manufactured by the firm''s plant in Juarez, Mexico from 12/10/2003 thru 2/5/2004. Model ER320, LIGACLIP ERCA Endoscopic Rotating Multiple Clip Appliers - Lot Codes: U4YV53 U4YV54 U4YV54 U4YV54 U4YX01 U4YX07 U4YX07 U4YX2Z U4YX2Z U4YX2Z U4YX2Z U4YX2Z U4YX7Y U4YX7Y U4YX7Y U4YX84 U4YY5R U4YY5R U4YY5T U4YY5T U4YY5T V4YZ0C V4YZ0C V4YZ82 V4YZ82 V4YZ84 V4YZ8H V4YZ8H V4Z02U V4Z106 V4Z106 V4Z106 V4Z111 V4Z111 V4Z111 V4Z14R V4Z14R V4Z14R V4Z14R V4Z14W V4Z15U V4Z15U V4Z215 V4Z215 V4Z21F V4Z333 V4Z333 V4Z335 V4Z335 V4Z388 V4Z388 V4Z52V V4Z52V V4Z52Z V4Z57M V4Z62M V4Z62M V4Z66A V4Z66A V4Z66C V4Z66C V4Z724 V4Z724 V4Z837 V4Z838 V4Z882 V4Z882 V4Z883 V4Z883 V4Z95F V4Z95F V4Z964 V4Z964 V4Z964 V4Z99R V4Z99R V4Z99W V4Z99W V4Z99W V4ZA0X V4ZA0X V4ZA3V V4ZA3V V4ZA53 V4ZA53 V4ZA53 V4ZC1D V4ZC1D V4ZC1U V4ZC1U V4ZD02 V4ZD06 V4ZD06 V4ZD3X V4ZD3X V4ZD3X V4ZD52 V4ZD52 V4ZD52 V4ZD9E V4ZD9E V4ZE0H V4ZE0H V4ZE0H V4ZE61 V4ZE61 V4ZE7L V4ZE7L Flex Tray Gastric Trays ¿ Kit Code: Lot Numbers: CBG17 V4Z63R CK017 U4YU9L CK017 U4YV4G CK017 U4YX3J CK017 U4YX5A CK017 U4YX5A CK017 U4YX5A CK017 U4YY23 CK017 V4YY8D CK017 V4YZ47 CK017 V4YZ47 CK017 V4Z00L CK017 V4Z24X CK017 V4Z36Y CK017 V4Z36Y CK017 V4Z45G CK017 V4Z52P CK017 V4Z52P CK017 V4Z52P CK017 V4Z52P CK017 V4Z60U CK017 V4Z77E CK017 V4Z88G CK017 V4Z932 CK017 V4ZA59 CK017 V4ZA9R Flex Tray Bariatric Trays ¿ Kit Code: Lot Numbers: FBW48 U4YX04 FBW48 V4Z344 FBW48 V4Z65G FBW48 V4ZD1C FBW64 V4Z829 FBW64 V4Z829 FBW64 V4ZE7K FBW79 U4YV5T FBW79 V4YZ53 FBW79 V4YZ53 FBW79 V4Z47T FBW79 V4Z62K FBW79 V4ZD1D FBW83 V4Z771 FBW83 V4Z771 FBW87 V4Z50Z KBW21 V4Z66D KBW21 V4ZC9T KBW21 V4ZC9T KBW29 V4Z797 KBW31 V4ZD48 KBW33 U4YV26 KBW33 U4YV26 KBW33 V4ZA3R KBW33 V4ZD1Y KBW47 V4Z16C KDW07 V4Z59L KDW07 V4Z59L KDW13 V4YZ3G KDW13 V4Z20W Flex Tray Access Trays ¿ Kit Code: Lot Numbers: FDA47 U4YV2K FDA47 V4Z209 FDA47 V4Z789 FDA47 V4ZA4G FDA47 V4ZA4G Flex Tray Cholecsystectomy Trays: Kit Code: Lot Numbers: FDC10 U4YU37 FDC10 U4YX1K FDC10 U4YY1L FDC10 V4Z26M FDC10 V4Z29H FDC10 V4Z49H FDC10 V4Z49H FDC10 V4Z49H FDC10 V4Z514 FDC10 V4Z65C FDC10 V4Z65C FDC10 V4Z86F FDC10 V4Z86F FDC10 V4Z93N FDC10 V4ZA8D FDC10 V4ZD6U FDC10 V4ZE0N FDC10 V4ZF23 FDC11 U4YX9N FDC11 V4Z910 FDC12 U4YV02 FDC12 U4YV02 FDC12 U4YX29 FDC12 U4YX29 FDC12 U4YX29 FDC12 U4YX29 FDC12 V4Z23A FDC12 V4Z945 FDC12 V4Z945 FDC12 V4ZA8M FDC12 V4ZA8M FDC13 U4YV03 FDC13 U4YV03 FDC13 V4Z137 FDC13 V4Z208 FDC13 V4Z208 FDC13 V4Z78C FDC13 V4ZC9Z FDC14 U4YU9X FDC14 V4Z83R FDC14 V4Z83R FDC15 U4YX27 FDC15 U4YX27 FDC15 V4Z22K FDC15 V4Z29E FDC15 V4Z37V FDC15 V4Z37V FDC15 V4Z93R FDC15 V4Z93R FDC15 V4Z957 FDC15 V4ZA62 FDC15 V4ZE0R FDC15 V4ZE0R FDC16 U4YU6G FDC16 U4YY4X FDC16 V4Z37A FDC16 V4Z49K FDC16 V4Z68K FDC16 V4Z68K FDC21 U4YW2T FDC21 V4Z93L FDC21 V4Z93L FDC22 U4YY52 FDC22 V4Z827 FDC22 V4ZC2M FDC22 V4ZC2M FDC22 V4ZC2M FDC22 V4ZC2M FDC32 U4YU3D FDC32 U4YX1L FDC32 U4YY6R FDC32 U4YY6R FDC32 V4Z59E FDC32 V4Z68H FDC32 V4Z68H FDC32 V4Z83U FDC32 V4Z83U FDC32 V4Z958 FDC32 V4Z958 FDC32 V4ZD55 FDC32 V4ZD57 FDC42 V4Z091 FDC42 V4Z95W FDC42 V4Z95W FDC42 V4Z95W FDC42 V4ZD5T FDC44 V4YY73 FDC46 V4Z150 FDC46 V4Z963 FDC46 V4Z963 FDC50 U4YV1Z FDC50 V4Z08G FDC50 V4ZE3D FDC56 V4Z83N FDC58 V4Z04A FDC58 V4Z04A FDC58 V4Z244 FDC58 V4Z86J FDC70 U4YX2A FDC70 V4Z896 FDC70 V4Z896 FDC70 V4ZD9U FDC70 V4ZF6F FDC79 U4YW3N FDC79 V4Z59H FDC79 V4Z59H FDC79 V4Z71X FDC79 V4Z71X FDC79 V4Z71X FDC80 V4Z39K FDC80 V4Z39K FDC80 V4Z39K FDC80 V4Z39K FDC81 U4YY0G FDC81 U4YY58 FDC81 U4YY58 FDC81 V4Z984 FDC81 V4Z984 FDC81 V4ZD5R FNC10 U4YW33 FNC10 V4Z27Y FNC10 V4Z71F FNC13 U4YV77 FNC13 V4Z561 FNC14 V4ZE3J FNC23 U4YU2F FNC23 U4YY47 FNC23 U4YY47 FNC23 V4Z50Y FNC23 V4ZD14 FNC28 U4YY0J FNC28 U4YY0J FNC28 V4Z20P FNC28 V4Z44R FNC28 V4Z44R FNC28 V4Z78A FNC28 V4ZC3V FNC28 V4ZC3V FNC29 U4YU03 FNC29 V4Z153 FNC29 V4Z17R FNC29 V4Z17R FNC29 V4ZC12 FNC29 V4ZC12 FNC30 U4YU21 FNC30 V4YZ3L FNC30 V4YZ3L FNC30 V4ZC17 FNC40 U4YW7K FNC40 V4Z181 FNC40 V4Z88N FNC40 V4ZE7T FNC40 V4ZE7T FNC41 U4YV01 FNC41 U4YV01 FNC41 V4Z26L FNC41 V4Z26L FNC41 V4Z515 FNC41 V4Z563 FNC41 V4Z69M FNC41 V4Z69M FNC41 V4Z86E FNC41 V4Z86E FNC41 V4Z86E FNC41 V4ZA2G FNC41 V4ZA2G FNC41 V4ZA2G FNC41 V4ZA2G FNC41 V4ZC1F FNC41 V4ZC1F FNC42 U4YV3T FNC42 V4Z04D FNC42 V4ZD4A FNC43 U4YW3M FNC43 U4YW3M FNC43 V4Z028 FNC43 V4Z028 FNC43 V4Z028 FNC43 V4Z612 FNC43 V4Z75G FNC43 V4ZE64 FNC62 V4Z26C FNC62 V4Z26C FNC62 V4Z71U FNC62 V4ZC5L FNC69 V4Z37W FNC69 V4ZC1P FNC72 U4YU9Z FNC72 V4Z56J FNC73 U4YY4D FNC73 U4YY4D FNC90 U4YT8L FNC90 V4YZ3R FNC90 V4YZ8W FNC90 V4YZ8W FNC90 V4Z89J FNC90 V4Z89J FNC90 V4ZC3W FNC92 U4YV5A FNC92 U4YV5A FNC92 V4Z891 FNC94 V4YY8L FNC94 V4YY8L FNC94 V4YY8L FNC94 V4YY8L FNC94 V4Z88M FNC94 V4Z88M FNC94 V4ZC3T FNC94 V4ZC3T FNC94 V4ZC3T FNC99 V4Z63M FTC10 V4Z15D FTC10 V4Z94A FTC11 U4YU01 FTC11 V4Z94C FTC15 U4YX03 FTC15 U4YX03 FTC15 V4YZ2A FTR12 U4YU06 FTR12 V4YZ7N FTR12 V4YZ7N FTR12 V4ZE26 FTR12 V4ZE26 FTR13 V4ZD1T FTR32 U4YU05 FTR32 U4YY06 FTR32 V4YY8M FTR32 V4YY8M FTR32 V4YY8M FTR72 U4YY4F FTR72 U4YY4F FTR72 V4Z12A FTR72 V4ZD49 FTR72 V4ZD49 FTR73 V4Z88P KBC01 U4YW7C KBC01 V4ZD9D KBC06 V4Z79A KBC06 V4ZG3Y KBC07 U4YW94 KBC07 U4YW94 KBC07 V4Z29D KBC07 V4Z67H KBC07 V4Z758 KBC11 V4Z30H KBC23 V4Z635 KDC01 U4YX23 KDC03 V4Z14P KDC06 V4YZ7J KDC25 V4Z23N KDC26 U4YV3V KDC26 V4YZ2H KDC26 V4YZ2H KDC26 V4Z20H KDC26 V4Z897 KDC27 V4YZ2M KDC27 V4Z914 KDC32 V4Z13P KDC32 V4Z898 KDC32 V4ZC6M KDC32 V4ZC6M KDC33 V4Z796 KDC33 V4ZD01 KDC35 U4YU9Y KDC39 U4YV5V KDC39 V4Z17M KDC39 V4Z81U KDC40 U4YV1R KDC40 U4YV1R KDC40 U4YV1R KDC40 V4Z08E KDC51 V4Z47R KDC53 V4Z227 KDC61 U4YV75 KDC61 V4YZ7H KDC61 V4Z23E KDC61 V4Z68M KDC61 V4ZC84 KDC68 U4YW76 KDC68 U4YY07 KDC68 U4YY1A KDC68 U4YY1A KDC68 V4ZE68 KDC84 U4YW32 KDC84 V4Z56H KDC84 V4Z83M KDC84 V4Z83M KDC84 V4ZD71 KDC94 V4Z73N KNC03 U4YW3H KNC03 V4Z243 KNC03 V4Z243 KNC03 V4ZE7V KNC03 V4ZE7V KNC04 V4Z072 KNC04 V4Z072 KNC04 V4Z610 KNC07 U4YU6A KNC07 V4Z047 KNC07 V4Z047 KNC07 V4Z351 KNC07 V4Z65K KNC07 V4Z65K KNC07 V4ZD66 KNC08 U4YV1T KNC09 V4Z56G KNC09 V4Z56G KNC09 V4Z62J KNC09 V4ZE57 KNC19 U4YV9C KNC19 V4Z119 KNC19 V4Z772 KNC19 V4ZD5N KNC35 U4YX06 KNC35 U4YX06 KNC35 V4Z26K KNC35 V4ZD5L KNC35 V4ZD5L KNC60 U4YT6N KNC60 V4Z63K KNC60 V4Z63K KNC60 V4Z83P KNC74 U4YV9D KNC74 U4YV9D KNC74 V4Z26D KNC74 V4Z62N KNC76 V4YZ5P TDC04 V4Z04N TDC07 V4Z71Z TDC07 V4Z71Z TDC07 V4Z71Z TDC09 V4Z29F TDC27 U4YT89 TDC27 V4Z427 TDC27 V4Z427 TDC27 V4ZD16 TDC34 U4YU04 TDC34 V4Z44H TDC34 V4Z44H TDC37 V4Z238 TDC37 V4Z238 TDC37 V4ZD5K TDC39 V4YZ3P TDC39 V4YZ3P TDC41 V4Z26A TDC45 V4Z27N TDC49 V4Z324 TDC51 V4Z326 TDC51 V4Z326 TDC52 U4YU69 TDC54 U4YX3C TDC54 U4YX3C TDC54 V4Z34Y TDC54 V4ZD4D TDC59 V4Z346 TDC59 V4Z346 TDC59 V4ZA48 TDC61 U4YV2D TDC64 U4YV9W TDC64 U4YV9W TDC72 U4YW2J TDC72 V4ZD6C TNC07 U4YV60 TNC07 V4Z22J TNC12 U4YU29 TNC12 V4Z50R TNC12 V4Z50R TNC18 U4YT88 TNC18 V4Z42X TNC18 V4ZF1P TNC18 V4ZF1P TNC20 U4YT8E TNC20 U4YX05 TNC20 U4YX05 TNC20 V4Z350 TNC20 V4Z350 TNC20 V4Z68L TNC23 V4Z12K TNC23 V4Z12K TNC23 V4Z13M TNC23 V4ZE3E TNC23 V4ZE3E TNC24 U4YV3Z TNC24 V4YY8V TNC24 V4YY8V TNC29 V4ZD17 TNC36 V4Z560 TNC36 V4ZE28 TNC36 V4ZE28 TNC36 V4ZE28 TNC45 V4YZ6P TNC45 V4YZ6P TNC49 V4Z239 TNC49 V4Z239 TNC49 V4Z56K TNC49 V4ZD15 TNC56 V4Z83K TNC61 U4YV76 TNC61 V4Z21X TNC63 V4YZ28 TNC63 V4YZ28 TNC63 V4YZ28 TNC63 V4YZ28 TNC63 V4Z62Y TNC63 V4ZD9C TNC71 U4YW8M TNC71 V4Z09F TNC71 V4Z37C TNC80 V4Z37G TNC80 V4Z54F TNC80 V4ZD13 TNC81 V4Z34Z TNC85 V4Z65J TNC85 V4Z65J TNC87 V4Z12D TNC87 V4ZC6Y TNC88 V4Z95T TNC90 V4YZ6N TNC90 V4YZ6N TNC90 V4Z60V TNC90 V4ZC85 TNG92 U4YW31 TNG92 V4Z12C TNG92 V4Z68F VDC10 U4YW3G VDC10 U4YY4E VDC10 V4Z599 VDC10 V4Z65F VDC10 V4Z949 VDC15 U4YW72 VDC15 U4YW72 VDC15 V4Z513 VDC15 V4Z71R VDC15 V4Z71R VDC32 U4YV00 VDC32 U4YY1M VDC32 U4YY1M VDC32 V4Z83T VNC41 U4YV3U VNC41 V4Z30L VNC41 V4Z30L VNC41 V4Z614 VNC41 V4Z75L VNC42 V4Z04C VNC42 V4Z356 VNC42 V4Z356 VNC42 V4ZC1R VNC43 U4YV41 VNC43 U4YV41 VNC43 V4Z569 VNC43 V4Z569 VNC43 V4Z965 VNC94 V4Z14Z Flex Tray General Laparoscopy Trays ¿ Kit Code: Lot Numbers: TGL21 U4YU02 TGL21 V4Z049 TGL21 V4Z049 TGL21 V4Z54D TGL32 V4Z029 TGL32 V4Z163 TGL44 V4Z449 TGL52 V4Z90Y
• Recalling Firm/ Manufacturer: Ethicon Endo-Surgery; 4545 Creek Rd; Cincinnati OH 45242-2803
• For Additional Information Contact: 513-337-7000
• Manufacturer Reason for Recall: This device is subject to recall due to an increased possibility of clip scissoring which can result in less than optimal clip formation which may or may not securely ligate tubular structures.
• FDA Determined Cause: Other
• Action: The firm contacted their customers via letter on June 7, 2004. The suspect product and Flex Tray kits will be returned and destroyed.
• Quantity in Commerce: 120,4015
• Distribution: The product was shipped to hospitals and distributors nationwide and worldwide.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = GDO