{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "94522", "product_res_number": "Z-0025-2011", "event_date_initiated": "2010-07-02", "event_date_posted": "2010-10-08", "recall_status": "Terminated", "event_date_terminated": "2011-06-28", "res_event_number": "56767", "product_code": "MJG", "k_numbers": [ "K982960" ], "product_description": "Tru-Core II Disposable Automatic Biopsy Instrument and Tru-Core II URO Disposable Automatic Biopsy Instrument. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recalling lot's for the product are as follows:\n\nModel Number: 763114100X\nLot #'s:\n92661WY5, 93211XXV, 00141YVE, 00541ZKX, 010920HL, 01522192, 92791X5I, 93271Y1W, 00201YYE, 00621ZQ3, 011320LH, 015221BD, 92791X7X, 93411Y9O, 00211Z0C, 00671ZRN, 011720Q, 015521CL, 92861XCT, 93421YBJ, 00251Z1T, 00761ZZP, 012420U0, 016221H2, 93001XLG, 93431YBI, 00351Z86, 0081201Y, 0138211F, 016721KJ, 93081XPC, 93571YJO, 00461ZE2, 0088206B, 0141215R, 93141XST, 00061YOV, 00541ZK0, 009620BO, 0146219M.\n\nModel Number: 763114160X\nLot #'s\n92661WY7, 00111YPZ, 00671ZRO, 013220Z7, 016221H7, 93131XLS, 00331Z61, 0110201Y, 014125Q, 00882065, 00391Z8Y, 013120YC, 015521CJ.\n\nModel Number: 763114200X\nLot #'s\n92661WY0, 00751ZYJ, 012420U1\n\nModel Number: 763116100X\nLot #'s\n92791X80, 93491YG9, 00331Z6M, 0083203O, 012420U3, 01672KL, 92791X81, 93501YGA, 00351Z8D, 009620BL, 013120Y9, 92931XDD, 00121YRT, 00431ZE1, 009920D3, 015221AX, 93001XLN, 00131YUG, 00541ZKV, 011020IU, 015221BE, 93081XPH, 00541ZJY, 00601ZOT, 011320LG, 015521CK, 93291Y43, 00251Z1R, 0081201W, 012020QC, 016221H3.\n\nModel Number: 763116160X\nLot #'s\n92661WY3, 00882068, 00351Z8A, 00761ZZQ, 012020QB, 016721KK, 92791X89, 00912084, 00471ZG0, 010320FM, 012420TZ, 92861XD4, 01472193, 00541ZK1, 010920HK, 0141215U, 93001XLR, 00151YVC, 00601ZOR, 0110201V, 015521CM, 93291Y40, 00331Z6J, 00701ZUX, 011720OP, 016221HS\n\n\n\n\nModel Number: 763116200X\nLot #'s\n121KN\n\nModel Number: 763116200X\nLot #'s\n92671X09, 00471ZG1, 00882067, 010320FN, 00211Z09, 00601ZOP, 009920D0, 011020IT\n\nModel Number: 763118100X\nLot #'s\n92661WY8, 93491YG7, 00331Z6L, 00621ZQ2, 009920D2, 0138213F, 92791X7Z, 93491YG8, 00351Z88, 00701ZUW, 010320FL, 01472194, 92861XDS, 00061YOT, 00471ZG2, 00761ZZO, 0110201W, 016221H4, 93091XPL, 00131YUF, 00541ZJZ, 0083203P, 012020QE, 93211XXW, 00251Z1S, 00541ZKU, 009620BM, 012420TX.\n\n\n\nModel Number: 763118160X\nLot #s\n92661WY6, 93271Y1V, 00201YYD, 00471ZG3, 012420U2, 016221GZ, 92671WZJ, 93411Y9P, 00251Z1Q, 00671ZRK, 013120YB, 92671WZK, 93421YBK, 00331Z6N, 00701ZUY, 013220Z9, 92861XD0, 00061YOW, 00351Z8E, 00882069, 015221BB, 93001XLM, 00111YQO, 00431ZE3, 009920D4, 015521CO.\n\n\nModel Number: 763118200X\nLot #s\n92861XCD, 93571YJN, 00331Z6K, 00671ZRM, 011320LF, 01382134, 93001XL6, 0061YOU, 00351Z89,00701ZUZ, 011720OO, 0141215S, 93001XLJ, 00912082, 00391Z8Z, 009620BQ, 012020QA, 01472195, 93081XPJ, 00111YQM, 00471ZG5, 009920D5, 013120Y8, 016221H1, 93211XXX, 00131YUD, 00481ZG4, 010320FJ, 013220Z6, 93400Y9K, 00201YYC, 00621ZQ1, 010920HJ, 0137211I.\n\n\nModel Number: 763120100X\nLot #s\n93001XLV, 00351Z8B, 0088206A, 01472196, 00331Z60, 00601ZOS, 01202QF.\n\n\nModel Number: 763120160X\nLot #s\n92661WY1, 00882066, 00111YQP, 00351Z8C, 013120YD, 01472197, 92861XDG, 00912083, 00211Z08, 00621ZQ5, 013220Z8.\n\n\nModel Number: 763120200X\nLot #s\n00351Z85, 012020QG, 012420TW.\n\nModel Number: 763418200X\nLot #s\n92671WZV, 93291Y41, 00351Z87, 00601ZNH, 010320FK, 0141215T, 92671WZW, 00061YOX, 00431ZE0, 0083203N, 0110201S, 015221BC, 92861XDH, 00131YUE, 00491ZIO, 009620BN, 0011720ON, 015521CN, 93081XPR, 00141YVB, 00541ZKT, 009920D1, 0138213E, 016221H6.\n\nModel Number: 763418250X\nLot #s\n92751X60, 00671ZRL,\n\n\nModel Number: 763418250X\nLot #s\n92661WY4, 93271Y1N, 00141YVD, 00601ZOQ, 0110201X, 013220ZA, 92751X6P, 93291Y42, 00211Z0B, 00761ZZR, 012020QD, 0137211G, 92781X5G, 93631YJP, 00221Z13, 0081201X, 012420TY, 01382133, 92861XDN, 00912085, 00431ZDZ, 009620BP, 013120YA, 016221H0.", "code_info": "The recalling lot's for the product are as follows:  Model Number: 763114100X Lot #'s: 92661WY5, 93211XXV, 00141YVE, 00541ZKX, 010920HL, 01522192, 92791X5I, 93271Y1W, 00201YYE, 00621ZQ3, 011320LH, 015221BD, 92791X7X, 93411Y9O, 00211Z0C, 00671ZRN, 011720Q, 015521CL, 92861XCT, 93421YBJ, 00251Z1T, 00761ZZP, 012420U0, 016221H2, 93001XLG, 93431YBI, 00351Z86, 0081201Y, 0138211F, 016721KJ, 93081XPC, 93571YJO, 00461ZE2, 0088206B, 0141215R, 93141XST, 00061YOV, 00541ZK0, 009620BO, 0146219M.  Model Number: 763114160X Lot #'s 92661WY7, 00111YPZ, 00671ZRO, 013220Z7, 016221H7, 93131XLS, 00331Z61, 0110201Y, 014125Q, 00882065, 00391Z8Y, 013120YC, 015521CJ.  Model Number: 763114200X Lot #'s 92661WY0, 00751ZYJ, 012420U1  Model Number: 763116100X Lot #'s 92791X80, 93491YG9, 00331Z6M, 0083203O, 012420U3, 01672KL, 92791X81, 93501YGA, 00351Z8D, 009620BL, 013120Y9, 92931XDD, 00121YRT, 00431ZE1, 009920D3, 015221AX, 93001XLN, 00131YUG, 00541ZKV, 011020IU, 015221BE, 93081XPH, 00541ZJY, 00601ZOT, 011320LG, 015521CK, 93291Y43, 00251Z1R, 0081201W, 012020QC, 016221H3.  Model Number: 763116160X Lot #'s 92661WY3, 00882068, 00351Z8A, 00761ZZQ, 012020QB, 016721KK, 92791X89, 00912084, 00471ZG0, 010320FM, 012420TZ, 92861XD4, 01472193, 00541ZK1, 010920HK, 0141215U, 93001XLR, 00151YVC, 00601ZOR, 0110201V, 015521CM, 93291Y40, 00331Z6J, 00701ZUX, 011720OP, 016221HS  Model Number: 763116200X Lot #'s 121KN  Model Number: 763116200X Lot #'s 92671X09, 00471ZG1, 00882067, 010320FN, 00211Z09, 00601ZOP, 009920D0, 011020IT    Model Number: 763118100X Lot #'s 92661WY8, 93491YG7, 00331Z6L, 00621ZQ2, 009920D2, 0138213F, 92791X7Z, 93491YG8, 00351Z88, 00701ZUW, 010320FL, 01472194, 92861XDS, 00061YOT, 00471ZG2, 00761ZZO, 0110201W, 016221H4, 93091XPL, 00131YUF, 00541ZJZ, 0083203P, 012020QE, 93211XXW, 00251Z1S, 00541ZKU, 009620BM, 012420TX.    Model Number: 763118160X Lot #s 92661WY6, 93271Y1V, 00201YYD, 00471ZG3, 012420U2, 016221GZ, 92671WZJ, 93411Y9P, 00251Z1Q, 00671ZRK, 013120YB, 92671WZK, 93421YBK, 00331Z6N, 00701ZUY, 013220Z9, 92861XD0, 00061YOW, 00351Z8E, 00882069, 015221BB, 93001XLM, 00111YQO, 00431ZE3, 009920D4, 015521CO.   Model Number: 763118200X Lot #s 92861XCD, 93571YJN, 00331Z6K, 00671ZRM, 011320LF, 01382134, 93001XL6, 0061YOU, 00351Z89,00701ZUZ, 011720OO, 0141215S, 93001XLJ, 00912082, 00391Z8Z, 009620BQ, 012020QA, 01472195, 93081XPJ, 00111YQM, 00471ZG5, 009920D5, 013120Y8, 016221H1, 93211XXX, 00131YUD, 00481ZG4, 010320FJ, 013220Z6, 93400Y9K, 00201YYC, 00621ZQ1, 010920HJ, 0137211I.   Model Number: 763120100X Lot #s 93001XLV, 00351Z8B, 0088206A, 01472196, 00331Z60, 00601ZOS, 01202QF.   Model Number: 763120160X Lot #s 92661WY1, 00882066, 00111YQP, 00351Z8C, 013120YD, 01472197, 92861XDG, 00912083, 00211Z08, 00621ZQ5, 013220Z8.   Model Number: 763120200X Lot #s 00351Z85, 012020QG, 012420TW.  Model Number: 763418200X Lot #s 92671WZV, 93291Y41, 00351Z87, 00601ZNH, 010320FK, 0141215T, 92671WZW, 00061YOX, 00431ZE0, 0083203N, 0110201S, 015221BC, 92861XDH, 00131YUE, 00491ZIO, 009620BN, 0011720ON, 015521CN, 93081XPR, 00141YVB, 00541ZKT, 009920D1, 0138213E, 016221H6.  Model Number: 763418250X Lot #s 92751X60, 00671ZRL,   Model Number: 763418250X Lot #s 92661WY4, 93271Y1N, 00141YVD, 00601ZOQ, 0110201X, 013220ZA, 92751X6P, 93291Y42, 00211Z0B, 00761ZZR, 012020QD, 0137211G, 92781X5G, 93631YJP, 00221Z13, 0081201X, 012420TY, 01382133, 92861XDN, 00912085, 00431ZDZ, 009620BP, 013120YA, 016221H0.", "firm_fei_number": "1036710", "recalling_firm": "Medical Device Technologies, Inc.", "address_1": "3600 Sw 47th Ave", "city": "Gainesville", "state": "FL", "postal_code": "32608-7555", "additional_info_contact": "Jayme Wilson \n352-338-0440 Ext. 350", "reason_for_recall": "Medical Device Technologies, Inc., dba Angiotech, Gaineville, Florida is recalling Tru-Core II Disposable Biopsy Devices due to compromised packaging integrity. The Tru-Core Disposable Automatic Biopsy Instrument is used to obtain multiple core samples from soft tissue such as liver, kidney, prostate, breast, ect. The recall is for the following Model Numbers: 763114100X, 763114160X, 763114", "root_cause_description": "Other", "action": "Angiotech sent an \"URGENT PRODUCT RECALL NOTIFICATION\" letter dated July 2, 2010 and response card to all customers including distributors. The letter described the product, problem and action to be taken by the customers. The customers were instructed to review their current inventory and segregate the affected lot numbers; arrange for return and replacement of the affected product, and complete and return the Customer Acknowledgment Form via fax to the Quality Assurance department at 1-352-338-0662 or 1-800-333-0440.\n\nIf you have any questions concerning this notification, contact Shannon Brooks at (352) 338-0440 ext 355 or Katrenia Williams at ext 353.", "product_quantity": "11,123 boxes (111,230 units)", "distribution_pattern": "Worldwide distribution: USA and countries including: Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Israel, Japan, New Zealand, Peru, South Africa, , Uruguay, and Venezuela.", "openfda": { "k_number": [ "K933324", "K080674", "K955683", "K922919", "K070836", "K925870", "K983647" ], "registration_number": [ "1423537", "2029275", "8030607", "3027518990", "3009888344", "1000632857", "3018242561", "1220477", "1526534", "9617744", "3007017524", "9612283", "3005012805", "1417485", "1721676", "3018094310", "9613926", "3006611221", "3008770707", "3004749705", "3000270450", "3007597038", "3011245468", "3009169953", "2183650", "3033858858", "3010071016", "3002806603", "1048735", "1643817", "9617601", "1423662", "3015173212", "3016688836", "9615857", "3008812560", "1644312", "2953359", "3009417901", "9615788", "3014579188", "3010131137", "9617429", "3005031160", "1526439", "3010097171", "3015831087", "1030489", "3003807268", "1216677", "1417592", "8010704", "8043792", "3008114965", "1836161", "3015399803", "9617616", "3005595283", "1928237", "9616088", "3009475067", "3005900820", "1820334", "3006975595", "1211566", "3004111573", "9611612", "1825146" ], "fei_number": [ "3002807847", "3027518990", "3009888344", "3002750084", "1000632857", "3018242561", "1220477", "1526534", "3002534070", "3007017524", "3005012805", "1417485", "1721676", "3002808529", "3018094310", "3006279007", "3002902735", "3008770707", "3004749705", "3000270450", "3001236905", "3011245468", "3009169953", "2183650", "3033858858", "3002807634", "1000402972", "3010071016", "3002806603", "1048735", "1643817", "3015173212", "3016688836", "3008812560", "3002807754", "1000306431", "3009417901", "3014579188", "3010131137", "3005031160", "3000215273", "3003854593", "1526439", "3003272754", "1000347621", "1000117748", "1000477302", "3010097171", "3015831087", "3003807268", "1216677", "3000215205", "1417592", "3008114965", "3005595283", "3015399803", "1928237", "3005900820", "3009475067", "3002807584", "3002409980", "3006509795", "1820334", "3002808269", "3006975595", "1211566", "3004111573", "1825146" ], "device_name": "Device, Percutaneous, Biopsy", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4800", "device_class": "1" } } ] }