BEUDAMED
    FDA Recall Terminated

    SAGB QuickClose Swedish Adjustable Gastric Band including Velocity" Injection Port and Applier. Product Code BD2XV, Lot #: 1040602, , 1040603, , 10270503, , 11020504, , 11030502, , 11090510, , 11090511, 1090512, 12030502, 12070502, 12070503, 12070504, 12200501, 12200502, 12200503, 12290505, 12290506, 01120603, 01200602, 01260601, 01260602, 01260603, 01260604, 02210605, 02210606, 02210607, 02280622, 02280623, 03080601, 03080602, 03080605, 03220611, 03220612, 05150601, 05150602, 05150603, 05150604, 05300613, 05300614, 06190606, 06190607, 06190608, 06190614, 06190615, 06190616, 06190617, 06190618, 06260601, 07060601, 07100605, 08140607, 08140608, 09050601, 09050602, 09050603, 09050604, 09050605, 09130601, 09130602, 09130603, 09130604, 09130605, 09180602, 09180603, 09180604, 09250602, 10110601, 10110602, 10110603, 20002024, 20002082, 20002185, 20002186, 20002193, 20002438, 20002439, 20002440, 20002441, 20002484, 20002485, 20003152, 20003153, 20003154, 20003155, 20003196, 20003362, 20003363, 20004437, 20004438, 20005244, 20005659, 20006819, 20006921, ZGNB43, ZGNB44, ZGNB45, ZGPBCC, ZGPBCD, ZGPBCJ, ZGPBCK, ZHBBBN, ZHBBBP, ZHBBBT, ZHCBB0, ZHCBB1, ZHCBB2, ZHCBB3, ZHCBB5, ZHCBB6, ZHCBB7, ZHCBB8, ZHCBB9, ZHDBF7, ZHFB76, ZHFB77, ZHFB79, ZHFBBW, ZHFBBY, ZHGBBJ, ZHGBDJ, ZHGBDK, ZHGBDL, ZHHBD6, ZHHBD7, ZHHBD8, ZHHBD9, ZHHBFB, ZHHBFC, ZHJBBJ, ZHJBBK, ZHJBBL, ZHJBBM, ZHJBBN, ZHJBBP, ZHMBDP, ZHNBC1, ZHNBC2, ZHPBBT, ZJBBBF, ZJBBDP, ZJCBB6, ZJCBDP, ZJCBGL, ZJDBBD, ZJDBBF, ZJDBBG, ZJDBBH, ZJDBBJ, ZJDBBK, ZJFBL6, ZJFBML, ZJHBCH, ZJHBK7, ZJJBC3, ZJKBC1, ZJKBHC, ZJKBK2, ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKFBDH, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV & ZLGBG5.

    Recall: Z-0302-2011 · Initiated September 27, 2010

    Recall

    Recall Number
    Z-0302-2011
    Event Number
    56938
    Firm
    Ethicon Endo-Surgery Inc
    FEI Number
    1527736
    Product Code
    LTI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 27, 2010
    Posted
    November 2, 2010
    Terminated
    November 18, 2011
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    SAGB QuickClose Swedish Adjustable Gastric Band including Velocity" Injection Port and Applier. Product Code BD2XV, Lot #: 1040602, , 1040603, , 10270503, , 11020504, , 11030502, , 11090510, , 11090511, 1090512, 12030502, 12070502, 12070503, 12070504, 12200501, 12200502, 12200503, 12290505, 12290506, 01120603, 01200602, 01260601, 01260602, 01260603, 01260604, 02210605, 02210606, 02210607, 02280622, 02280623, 03080601, 03080602, 03080605, 03220611, 03220612, 05150601, 05150602, 05150603, 05150604, 05300613, 05300614, 06190606, 06190607, 06190608, 06190614, 06190615, 06190616, 06190617, 06190618, 06260601, 07060601, 07100605, 08140607, 08140608, 09050601, 09050602, 09050603, 09050604, 09050605, 09130601, 09130602, 09130603, 09130604, 09130605, 09180602, 09180603, 09180604, 09250602, 10110601, 10110602, 10110603, 20002024, 20002082, 20002185, 20002186, 20002193, 20002438, 20002439, 20002440, 20002441, 20002484, 20002485, 20003152, 20003153, 20003154, 20003155, 20003196, 20003362, 20003363, 20004437, 20004438, 20005244, 20005659, 20006819, 20006921, ZGNB43, ZGNB44, ZGNB45, ZGPBCC, ZGPBCD, ZGPBCJ, ZGPBCK, ZHBBBN, ZHBBBP, ZHBBBT, ZHCBB0, ZHCBB1, ZHCBB2, ZHCBB3, ZHCBB5, ZHCBB6, ZHCBB7, ZHCBB8, ZHCBB9, ZHDBF7, ZHFB76, ZHFB77, ZHFB79, ZHFBBW, ZHFBBY, ZHGBBJ, ZHGBDJ, ZHGBDK, ZHGBDL, ZHHBD6, ZHHBD7, ZHHBD8, ZHHBD9, ZHHBFB, ZHHBFC, ZHJBBJ, ZHJBBK, ZHJBBL, ZHJBBM, ZHJBBN, ZHJBBP, ZHMBDP, ZHNBC1, ZHNBC2, ZHPBBT, ZJBBBF, ZJBBDP, ZJCBB6, ZJCBDP, ZJCBGL, ZJDBBD, ZJDBBF, ZJDBBG, ZJDBBH, ZJDBBJ, ZJDBBK, ZJFBL6, ZJFBML, ZJHBCH, ZJHBK7, ZJJBC3, ZJKBC1, ZJKBHC, ZJKBK2, ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKFBDH, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV & ZLGBG5.

    Reason

    The Tubing Strain Relief component of the Injection Port may detach from the Locking Connector, and migrate from its original position on the Locking Connector. This may result in: Tubing Strain Relief migrating on the Tubing; Kinking of the Tubing resulting in difficulty/inability to adjust the fluid volume within the Band; or a free foreign body in the abdominal wall or abdominal (peritoneal) ca

    Action

    Ethicon Endo-Surgery issued an Urgent : Devoced Recall Event 2240 letter dated October 8, 2010 to all consignees identifying the affected devices and actions to be taken. Consignees were instructed: DO NOTt use product from the affected lots, but implanted devices do not need to be removed as part of this recall. Examine inventory and remove the affected product. If they DO have the affected product, complete the Business Reply Form, keeping a copy for records, and place the original form in the box with the product to be returned, affix the pre-printed label, and return to Stericycle. If they DO NOT have the affected product, complete the Business Reply Form, and fax it to Stericycle. A redesigned replacement product will be sent out to consignees within 30-60 days of product return. Ethicon Endo-Surgery can be contacted at 513 337-8208 concerning this recall.

    Distribution

    Worldwide Distribution: USA including the following states: AK, AL, AR, AZ, CA, CO, CT, Washington DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI and WV, and the following countries: ARAB EMIRATES, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUATEMALA, HONG KONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KOREA, KUWAIT, LIBYA, MEXICO, NETHERLANDS, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, PUERTO RICO, RUSSIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, TAIWAN, THAILAND, TURKEY and VENEZUELA.

    Quantity

    26,966 pieces