ENDOPATH XCEL" with OPTIVIEW" Technology trocar Product Codes: Product Code #: 03B11LP-Lot #'s: G4RW5U, G4RZ7L, G4T33Y & G4T58C. Product Code #: 03B11LPH- Lot #'s: G4RX8G, G4RZ3X & G4T03X. Product Code #: 03B11LT- Lot #'s: G4RH57, G4RH49, G4RJ9H, G4RK2U, G4RK90, G4RL5P, G4RM16, G4RM1F, G4RM7E,G4RN1E, G4RP3L, G4RT0T, G4RT9D, G4RV4M, G4RV4D, G4RW9Z, G4RX5R, G4RY23, G4RY7P, G4RZ6G, G4T093, G4T167, G4T22M, G4T27A, G4T27W, G4TC7V, G4TD1U, G4TE1P, G4TF0N, G4TF3J, G4TH07, G4TG6D, G4TH5L, G4TJ44, G4TK1J, G4TK6E, G4TL3A, G4TL95, G4TM49, G4TM88, G4TN2H, G4TN88, G4TP1R, G4TP4X, G4TP89,G4TR4X, G4TT3K, G4TT97, G4TU8J, G4TV4W, G4TW1C, G4TX0C & G4TX8Z. Product Code #: 03B11LTH-Lot #'s: G4RW20, G4T03Y, G4T26Y, G4T49F, G4T73A, G4TX0R & G4TX9D. Product Code # 03B12LP-Lot #'s: G4RV5F, G4RY26, G4T27X, G4T55H & G4T75Y. Product Code #: 03B12LPH-Lot #'s: G4RW5T, G4RZ3Y, G4T03Z, G4T32C & G4T49G. Product Code #: 03B12LT-Lot #'s: F4PX6F, F4PZ4D, F4PZ22, F4PY9K, F4PY9E, F4PZ6F, F4PZ9Z, F4R01X, F4R039, F4R00M, F4R09W, F4R10Z, F4R15N, F4R18K, F4R18E, F4R234, F4R255, F4R278, F4R256, F4R35D, F4R34N, F4R34L, F4R369, F4R393, F4R40J, F4R44A, F4R458, G4R601, G4R71Y, G4R71Z, G4R80H, G4R77Z, G4R77Y, G4R860, G4R87V, G4R920, G4R915, G4R962, G4R97Z, G4R84L, G4RA7D, G4RA8N, G4RC45, G4RC79, G4RC8D, G4RC98, G4RD2A, G4RC8E, G4RD24, G4RD4V, G4RE84, G4RG18, G4RG3T, G4RG83, G4RF0A, G4RH0C, G4RG31, G4RG32, G4RF8C, G4RJ08, G4RJ92, G4RJ9E, G4RK6L, G4RL02, G4RL1L, G4RL2E,G4RL8P, G4RL8Y, G4RM31, G4RM49, G4RN06, G4RN27, G4RN30, G4RN2K, G4RN5D, G4RN8F, G4RN7Z, G4RP1K, G4RR2N, G4RR3K, G4RT28, G4RT09, G4RT3G, G4RT3J,G4RU8H, G4RV1F, G4RV1G, G4RV89, G4RV8J, G4RW55, G4RW54, G4RX59, G4RZ15, G4RY7W, G4RY8V, G4RY8W, G4RZ29, G4RZ6W, G4RZ6V, G4RZ6H, G4RZ6U, G4T01U, G4T04J, G4T04H, G4T14X, G4T23R, G4T296, G4T34K, G4T36A, G4T34P, G4T41E, G4T44W, G4T46C, G4T45N, G4T50W, G4T529, G4T63Z, G4T66H, G4T64N, G4T66J, G4T750, G4T70Y, G4T711, G4T73J, G4T78T, G4T81R, G4T78U, G4T83Y, G4T93A, G4T87T, G4T95J, G4T90T, G4T89V, G4T94W, G4T941, G4T940, G4T976, G4TA1E, G4TA5W, G4TA7D, G4TA5X, G4TA9H,G4TA96, G4TC3Y, G4TC4Y, G4TC4X, G4TC80, G4TD3W, G4TD3G, G4TF02, G4TD8Z, G4TD9Z, G4TF8Z, G4TG0W, G4TG31, G4TG4H, G4TG6X, G4TH16, G4TH5M, G4TH79, G4TJ2A, G4TJ6U, G4TJ5W, G4TJ8Y, G4TJ9W, G4TK2F, G4TK86, G4TK9H, G4TL5Z, G4TL7R, G4TL9N, G4TM5T, G4TM3H, G4TM87, G4TP14, G4TR1F, G4TP7K, G4TR54, G4TR3A, G4TR7H, G4TR9M, G4TT0G, G4TT20, G4TT43, G4TT7R, G4TU1D, G4TU3J, G4TV22, G4TU89, G4TW0N, G4TV5V, G4TW3V, G4TW5U, G4TX16, G4TX2D, G4TX8R, G4TX7E & G4TY19. Product Code #: 03B12LTH- Lot #'s: G4RW31, G4RW2R, G4RZ48, G4T00F, G4T27C, G4T448, G4T56N, G4T549, G4T59L, G4T65G, G4T709, G4TE35, G4TF2E, G4TG03, G4TG73, G4TH21, G4TM00, G4TT3F, G4TU3P &G4TX0T. Product Code #: 03B12SRT- Lot #'s: G4RW52, G4RZ25, G4T05J, G4T465 & G4T76T. Product Code #: 04B12XT-Lot #'s: G4RU2U, G4RW8N, G4RV59, G4RW97, G4T19T, G4T79U, G4TA2A, G4TA7K, G4TD2C, G4TF0R, G4TJ1L, G4TM3X, G4TN8E, G4TR00, G4TT2W, G4TW4E, G4TW55 & G4TY7G. Product Code #'s: 03CB11LT-Lot #'s: G4RH8R, G4RK9Z, G4RL5R, G4RM8H, G4RN6Z, G4RT08, G4RV2F, G4RY0X, G4RZ5N, G4T12D, G4T20J, G4T31F, G4T444, G4T50E, G4TL5Y, G4TL8F, G4TU70 & G4TX6J. Product Code #: 03CB12LT-Lot Code #'s: F4R421, G4R93M, G4R989, G4RA4E, G4RA7Z, G4RA8M, G4RC4N, G4RD94, G4RG1F, G4RG4X, G4RG91, G4RH7X, G4RJ9A, G4RN3R, G4RR4T, G4RT8H, G4RU3C, G4RU6V, G4RV2U, G4RW9J, G4RY1R, G4RY6L, G4RZ68, G4T092, G4T14D, G4T229, G4T243, G4T26W, G4T31T, G4T32W, G4T37M, G4T37N, G4T410, G4T449, G4T45Z, G4T47R, G4T48G, G4T551, G4T71V, G4T74Z, G4T81K, G4T83U, G4T894, G4T92T, G4T98R, G4TA4Z, G4TA9X, G4TC2L, G4TC6L, G4TD1E, G4TD68, G4TE07, G4TE9W, G4TF2M, G4TG16, G4TG61, G4TG8P, G4TH58, G4TJ2G, G4TJ99, G4TK3H, G4TK1H, G4TL76, G4TM3D, G4TM5W, G4TN2E, G4TN81, G4TP0V, G4TP9D, G4TR4W, G4TR77, G4TU0L, G4TU86, G4TV4F, G4TV9F, G4TW9U & G4TX7P. Product Code #: 02D11LT- Lot Code #'s: G4RR2U, G4RR34, G4RT5N, G4RT47, G4RT53, G4RU05, G4RX11, G4RX7V, G4RZ28, G4RZ4M, G4T06C, G4T09H, G4T171, G4T18U, G4T28K, G4T38Y, G4T46L, G4T51N, G4T55T, G4T590, G4
FDA Recall Z-0336-2011 · Posted None
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Reason for Recall
Firm Action
Root Cause
Device Design
Distribution Pattern
Worldwide distribution: USA, ARGENTINA, AUSTRALIA, BELGIUM,BRAZIL,CANADA,CHILE,CHINA,COLOMBIA,COSTA RICA, DOMINICAN REPUBLIC,ECUADOR, EL SALVADOR, GREECE, GUATEMALA, HONG KONG, ISRAEL, ITALY, JAPAN, JORDAN, KOREA, REPUBLIC OF, LEBANON, NETHERLANDS ANTILLES, NICARAGUA, PANAMA SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA SPAIN, TRINIDAD AND TOBAGO, UNITED ARAB EMIRATES URUGUAY, and VENEZUELA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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