PlainRecordsFDA · Medical device recall
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320)… and 2 more products
- Date
- July 31, 2013
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Terminated
- Filed by
- Ethicon Endo-Surgery Inc
- Reason
- Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
- Distribution pattern
- Worldwide Distribution - USA Nationwide to all fifty (50) states, and internationally including the following countries: ARGENTINA, ARGENTINA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, ECUADOR, EGYPT, EL SALVADOR, GREECE, HONDURAS, INDIA, INDONESIA, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA and YEMEN.
3 products in this recall
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320)…
- Product
- LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360¿ in either direction. The rotating knob is located to allow for a one-handed technique.
- Quantity
- 738,356
- Codes and lots
- H44Z7W, 37ER320, 01/03/12 to 11/15/16; J4A016, 37ER320, 01/05/12 to 12/15/16; J4A11G, 37ER320, 01/10/12 to 12/15/16; J4A124, 37ER320, 01/10/12 to 12/15/16; J4A145 37ER320, 01/11/12 to 12/15/16 J4A182, 37ER320, 01/13/12 to 12/15/16; J4A21T, 37ER320, 01/27/12 to 12/15/16; J4A28D, 37ER320, 01/19/12 to 12/15/16; J4A28U, 37ER320, 01/19/12 to 12/15/16; J4A335, 37ER320, 01/23/12 to 12/15/16; J4A38L, 37ER320, 01/25/12 to 12/15/16; J4A39D, 37ER320, 01/26/12 to 12/15/16; J4A406, 37ER320, 01/26/12 to 12/15/16; J4A40P, 37ER320, 02/07/12 to 12/15/16; J4A45T, 37ER320, 01/29/12 to 12/15/16; J4A461, 37ER320, 01/30/12 to 12/15/16; J4A46T, 37ER320, 01/30/12 to 12/15/16; J4A48U,), 37ER320, 02/02/12 to 12/15/16; J4A49L, 37ER320, 02/01/12 to 12/15/16; J4A525, 37ER320, 02/02/12 to 12/15/16; J4A535, 37ER320, 02/02/12 to 12/15/16; J4A559, 41XBB48B 02/02/12 to 07/15/16; J4A60K, 37ER320, 02/08/12 to 01/15/17; J4A60W, 37ER320, 02/08/12 to 01/15/17; J4A61Z, 37ER320, 02/08/12 to 01/15/17; J4A62E, 37ER320, 02/08/12 to 01/15/17; J4A62U, 37ER320, 02/09/12 to 01/15/17; J4A71W, 37ER320, 02/15/12 to 01/15/17; J4A729, 37ER320, 02/15/12 to 01/15/17; J4A73H, 37ER320, 02/15/12 to 01/15/17; J4A743, 37ER320, 02/16/12 to 01/15/17; J4A74T, 37ER320, 02/16/12 to 01/15/17; J4A755, 37ER320, 02/16/12 to 01/15/17; J4A75P, 37ER320, 02/16/12 to 01/15/17; J4A86E, 37ER320, 02/24/12 to 01/15/17; J4A871, 37ER320, 02/25/12 to 01/15/17; J4A87L, 37ER320, 02/25/12 to 01/15/17; J4A889, 37ER320, 02/25/12 to 01/15/17; J4A92X, 41XBB48B 02/28/12 to 08/15/16; J4A97H, 37ER320, 03/02/12 to 01/15/17; J4A98T, 37ER320, 03/02/12 to 01/15/17; J4A997, 37ER320, 03/03/12 to 01/15/17; J4A99V, 37ER320, 03/03/12 to 02/15/17; J4AAOM, 37ER320, 03/03/12 to 02/15/17; J4AA1H, 37ER320, 03/05/12 to 02/15/17; J4AA71, 37ER320, 03/07/12 to 02/15/17; J4AA7V, 37ER320, 03/08/12 to 02/15/17; J4AA84, 37ER320, 03/08/12 to 02/15/17; J4AA9D, 37ER320, 03/08/12 to 02/15/17; J4AC2X, 37ER320, 03/10/12 to 02/15/17; J4AD09, 37ER320, 03/15/12 to 02/15/17; J4AD1A, 37ER320, 03/15/12 to 02/15/17; J4AD2G, 37ER320, 03/16/12 to 02/15/17; J4AE3W, 37ER320, 03/22/12 to 02/15/17; J4AE49, 37ER320, 03/22/12 to 02/15/17; J4AE57, 37ER320, 03/23/12 to 02/15/17; J4AE63, 37ER320, 03/23/12 to 02/15/17; J4AE6R, 37ER320, 04/13/12 to 02/15/17; J4AE7E, 37ER320, 04/11/12 to 02/15/17; J4AE86, 37ER320, 03/24/12 to 02/15/17; J4AE8L, 37ER320, 03/24/12 to 02/15/17; J4AF09, 41XBB48B, 03/27/12 to 10/15/16 84; J4AF15, 37ER320, 03/28/12 to 02/15/17; J4AF1N, 37ER320, 03/28/12 to 02/15/17; J4AF2G, 37ER320, 03/28/12 to 02/15/17; J4AF3K, 37ER320, 03/28/12" 02/15/17; J4AF48, 37ER320, 03/29/12 to 02/15/17; J4AF4J, 37ER320, 03/29/12 to 02/15/17; J4AGOV, 37ER320, 04/03/12 to 02/15/17; J4AG4V, 37ER320, 04/05/12 to 03/15/17; J4AG91, 37ER320, 04/11/12 to 03/15/17; J4AG9G, 37ER320, 04/18/12 to 03/15/17; J4AHOV, 37ER320, 04/12/12 to 03/15/17; J4AH8N, 37ER320, 04/15/12 to 03/15/17; J4AH96, 37ER320, 04/16/12 to 03/15/17; J4AH9C, 37ER320, 04/16/12 to 03/15/17; J4AH9R, 37ER320, 04/16/12 to 03/15/17; J4AJ3A, 37ER320, 04/18/12 to 03/15/17; J4AJ3T, 37ER320, 04/18/12 to 03/15/17; J4AJ6P, 37ER320, 04/20/12 to 03/15/17; J4AJ7M, 37ER320, 04/20/12 to 03/15/17; J4AKOP, 37ER320, 04/21/12 to 03/15/17; J4AK14, 37ER320, 04/22/12 to 03/15/17; J4AK1H, 37ER320, 04/23/12 to 03/15/17; J4AK1R, 37ER320, 04/23/12 to 03/15/17; J4AK2V, 37ER320, 04/24/12 to 03/15/17; J4AK35, 37ER320, 04/24/12 to 03/15/17; J4AK40, 37ER320, 04/24/12 to 03/15/17; J4AK5U, 37ER320, 04/25/12 to 03/15/17; J4AK67, 37ER320, 04/25/12 to 03/15/17; 2136; J4AK7D, 37ER320, 04/26/12 to 03/15/17; J4AK8C, 37ER320, 04/26/12 to 03/15/17; 1152; 4AK9R, 37ER320, 04/28/12 to 03/15/17; J4ALOU, 37ER320, 04/27/12 to 03/15/17; J4AL65, 37ER320, 05/02/12 to 03/15/17; J4AL6P, 37ER320, 05/02/12 to 03/15/17; 2172; J4AL87, 37ER320, 05/11/12 to 03/15/17; 2244; J4AL90, 37ER320, 05/03/12 to 04/15/17; J4AL9H, 37ER320, 05/03/12 to 04/15/17; J4AM11, 37ER320, 05/03/12 to 04/15/17; J4AM1K, 37ER320, 05/04/12 to 04/15/17; J4AM2E, 37ER320, 05/04/12 to 04/15/17; J4AM32, 37ER320, 05/04/12 to 04/15/17; J4AM3G, 37ER320, 05/05/12 to 04/15/17; J4AM45, 37ER320, 05/05/12 to 04/15/17; J4AM7R, 37ER320, 05/08/12 to 04/15/17; J4AM7W, 37ER320, 05/08/12 to 04/15/17; J4AM8H, 37ER320, 05/09/12 to 04/15/17; J4AM9J, 37ER320, 05/09/12 to 04/15/17; J4ANOC, 37ER320, 05/09/12 to 04/15/17; J4AN14, 37ER320, 05/09/12 to 04/15/17; J4AN1P, 37ER320, 05/10/12 to 04/15/17; J4AN1X, 37ER320, 05/10/12 to 04/15/17; J4AN2K, 37ER320, 05/10/12 to 04/15/17; J4AN35, 37ER320, 05/10/12 to 04/15/17; J4AR7E, 41XBB48B 05/24/12 to 01/15/17; J4AT2G, 37ER320, 06/02/12 to 04/15/17; 1152; J4AT2H, 37ER320, 05/31/12 to 04/15/17; J4AUOH, 37ER320, 06/04/12 to 04/15/17; J4AU23, 37ER320, 06/04/12 to 04/15/17; J4AU29, 37ER320, 06/05/12 to 05/15/17; J4AU2V, 37ER320, 06/05/12 to 05/15/17; J4AV5J, 37ER320, 06/12/12 to 05/15/17; J4AV5T, 37ER320, 06/12/12 to 05/15/17; J4AW02, 37ER320, 06/13/12 to 05/15/17; J4AWOG, 37ER320, 06/14/12 to 05/15/17; J4AW7D, 37ER320, 06/18/12 to 05/15/17; J4AW7N, 37ER320, 06/18/12 to 05/15/17; J4AW86, 37ER320, 06/19/12 to 05/15/17; J4AX78, 37ER320, 06/23/12 to 05/15/17; J4AX7M, 37ER320, 06/23/12 to 05/15/17; J4AX84, 37ER320, 06/24/12 to 05/15/17; J4AX8M, 37ER320, 06/24/12 to 05/15/17; J4AY22, 37ER320, 06/26/12 to 05/15/17; J4AY23, 37ER320, 06/27/12 to 05/15/17; J4AY24, 37ER320, 06/27/12 to 05/15/17; J4AY26, 37ER320, 06/27/12 to 05/15/17; J4AY7E, 37ER320, 06/29/12 to 05/15/17; J4AY8R, 37ER320, 06/29/12 to 05/15/17; J4AY9D, 37ER320, 07/09/12 to 05/15/17; J4AZOL, 37ER320, 07/02/12 to 05/15/17; J4AZ1X, 37ER320, 07/11/12 to 05/15/17; J4AZ2H, 37ER320, 07/03/12 to 06/15/17; J4AZ6R, 37ER320, 07/06/12 to 06/15/17; J4AZ7K, 37ER320, 07/06/12 to 06/15/17; J4C04N, 37ER320, 07/11/12 to 06/15/17; J4C059, 37ER320, 07/12/12 to 06/15/17; J4C08U, 37ER320, 07/13/12 to 06/15/17; J4C09E, 37ER320, 07/14/12 to 06/15/17; J4C12Y, 37ER320, 07/16/12 to 06/15/17; J4C14F, 37ER320, 07/18/12 to 06/15/17; J4C16V, 37ER320, 07/18/12 to 06/15/17; J4C216, 37ER320, 07/23/12 to 06/15/17; J4C21H, 37ER320, 07/24/12 to 06/15/17; J4C21N, 37ER320, 07/24/12 to 06/15/17; J4C22M, 37ER320, 07/24/12 to 06/15/17; J4C30T, 37ER320, 07/27/12 to 06/15/17; J4C31J, 37ER320, 07/28/12 to 06/15/17; J4C32M, 37ER320, 08/21/12 to 06/15/17; J4C332, 37ER320, 07/30/12 to 06/15/17; J4C399, 37ER320, 08/03/12 to 06/15/17; J4C41U, 37ER320, 08/06/12 to 07/15/17; J4C42C, 37ER320, 08/04/12 to 07/15/17; J4C42X, 37ER320, 08/03/12 to 07/15/17; J4C45J, 37ER320, 08/07/12 to 07/15/17; J4C46Y, 37ER320, 08/07/12 to 07/15/17; J4C47A, 37ER320, 08/07/12 to 07/15/17; J4C489, 37ER320, 08/08/12 to 07/15/17; J4C49Y, 37ER320, 08/08/12 to 07/15/17; J4C508, 37ER320, 08/09/12 to 07/15/17; J4C510, 37ER320, 08/09/12 to 07/15/17; J4C57X, 37ER320, 08/14/12 to 07/15/17; J4C59E, 37ER320, 08/14/12 to 07/15/17; J4C606, 37ER320, 08/15/12 to 07/15/17; J4C65Z, 37ER320, 08/18/12 to 07/15/17; J4C66P, 37ER320, 08/20/12 to 07/15/17; J4C678, 37ER320, 08/21/12 to 07/15/17; J4C67K, 37ER320, 08/21/12 to 07/15/17; J4C762, 37ER320, 08/24/12 to 07/15/17; J4C765, 37ER320, 08/24/12 to 07/15/17; J4C76T, 37ER320, 08/24/12 to 07/15/17; J4C84K, 37ER320, 08/30/12 to 07/15/17; J4C84Z, 37ER320, 08/30/12 to 07/15/17; J4C90P, 37ER320, 09/05/12 to 07/15/17; J4C91H, 37ER320, 09/02/12 to 07/15/17; J4C91W, 37ER320, 09/05/12 to 07/15/17; J4C92P, 37ER320, 09/05/12 to 07/15/17; J4C96L, 37ER320, 09/06/12 to 08/15/17; J4C97D, 37ER320, 09/06/12 to 08/15/17; J4C97Z, 37ER320, 09/07/12 to 08/15/17; J4C98X, 37ER320, 09/07/12 to 08/15/17; J4CA3A, 37ER320, 09/11/12 to 08/15/17; J4CA4L, 37ER320, 09/11/12 to 08/15/17; J4CA62, 37ER320, 09/12/12 to 08/15/17; J4CA6K, 37ER320, 09/12/12 to 08/15/17; J4CA7F, 37ER320, 09/13/12 to 08/15/17; J4CA7J, 37ER320, 09/13/12 to 08/15/17; J4CA96, 37ER320, 09/13/12 to 08/15/17; J4CA9V, 37ER320, 09/13/12 to 08/15/17; J4CC63, 37ER320, 09/19/12 to 08/15/17; J4CD25, 42XBB48B 09/21/12 to 02/15/17; J4CD4R, 37ER320, 09/21/12 to 08/15/17; J4CD5H, 37ER320, 09/22/12 to 08/15/17; J4CD6D, 42XBB48B 09/25/12 to 02/15/17; J4CD6R, 37ER320, 09/25/12 to 08/15/17; J4CD8F, 42XBB48B 09/27/12 to 02/15/17; J4CE05, 37ER320, 09/26/12 to 08/15/17; J4CEOA, 37ER320, 09/26/12 to 08/15/17; J4CE1U, 37ER320, 09/26/12 to 08/15/17; J4CF6M, 37ER320, 10/05/12 to 09/15/17; J4CF6P, 37ER320, 10/05/12 to 09/15/17; J4CF7E, 37ER320, 10/05/12 to 09/15/17; J4CF7R, 37ER320, 10/06/12 to 09/15/17; J4CF80, 37ER320, 10/06/12 to 09/15/17; J4CF8X, 37ER320, 10/08/12 to 09/15/17; J4CGOP, 37ER320, 10/09/12 to 09/15/17; J4CG17, 37ER320, 10/10/12 to 09/15/17; J4CG1U, 37ER320, 10/10/12 to 09/15/17; J4CG2U, 37ER320, 10/10/12 to 09/15/17; J4CG37, 37ER320, 10/10/12 to 09/15/17; J4CG4L, 37ER320, 10/11/12 to 09/15/17; J4CG66, 37ER320, 10/11/12 to 09/15/17; J4CG8R, 37ER320, 10/16/12 to 09/15/17; J4CG8X, 37ER320, 10/16/12 to 09/15/17; J4CH10, 37ER320, 10/15/12 to 09/15/17; J4CH4U, 37ER320, 10/17;/12 to 09/15/17; J4CH4V, 37ER320, 11/16/12 to 09/15/17; J4CH97, 37ER320, 10/20/12 to 09/15/17; J4CH9R, 37ER320, 10/20/12 to 09/15/17; J4CJ17, 37ER320, 10/20/12 to 09/15/17; J4CJ61, 37ER320, 10/25/12 to 09/15/17; J4CJ6L, 37ER320, 10/25/12 to 09/15/17; J4CKOV, 37ER320, 10/27/12 to 09/15/17; J4CK16, 37ER320, 10/29/12 to 09/15/17; J4CK3L, 37ER320, 10/30/12 to 09/15/17; J4CK9D, 37ER320, 11/02/12 to 09/15/17; J4CK9J, 37ER320, 11/02/12 to 09/15/17; J4CL23, 37ER320, 11/03/12 to 10/15/17; J4CL3F, 37ER320, 11/06/12 to 10/15/17; J4CL3U, 37ER320, 11/06/12 to 10/15/17; J4CL49, 37ER320, 11/06/12 to 10/15/17; J4CL8D, 37ER320, 11/08/12 to 10/15/17; J4CL9A, 37ER320, 11/08/12 to 10/15/17; J4CL9Z, 37ER320, 11/17;/12 to 10/15/17; J4CN1C, 37ER320, 11/15/12 to 10/15/17; J4CN9T, 37ER320, 11/20/12 to 10/15/17; J4CP1P, 37ER320, 11/27/12 to 10/15/17; J4CP1Y, 37ER320, 11/27/12 to 10/15/17; J4CP4C, 37ER320, 11/27/12 to 10/15/17; J4CP4L, 37ER320, 11/27/12 to 10/15/17; J4CP8U, 37ER320, 11/29/12 to 10/15/17; J4CR1C, 37ER320, 11/30/12 to 10/15/17; J4CR3L, 37ER320, 12/04/12 to 10/15/17; J4CR44, 37ER320, 12/04/12 to 10/15/17; J4CR6Y, 37ER320, 12/04/12 to 11/15/17; J4CR7X, 37ER320, 12/07/12 to 11/15/17; J4CT1U, 37ER320, 12/07/12 to 11/15/17; J4CT27, 37ER320, 12/09/12 to 11/15/17; J4CTSR, 37ER320, 12/11/12 to 11/15/17; J4CU1U, 37ER320, 12/12/12 to 11/15/17; J4CU27, 37ER320, 12/12/12 to 11/15/17; J4CU3K, 37ER320, 12/14/12 to 11/15/17; J4CU68, 37ER320, 12/15/12 to 11/15/17; J4CV2F, 37ER320, 12/20/12 to 11/15/17; J4CV48, 37ER320, 12/20/12 to 11/15/17; J4CV4J, 37ER320, 12/21/12 to 11/15/17; J4CV4U, 37ER320, 12/21/12 to 11/15/17; J4CV58, 37ER320, 12/21/12 to 11/15/17; J9002K, 41XCB57S 01/03/12 to 12/15/16; J9002L, 41XCD52S 01/03/12 to 12/15/16; J9003P, 02CK017 01/05/12 to 12/31/99; J90058, 41XCC51S 01/06/12 to 12/15/16; J90078, 41XCDS15 01/05/12 to 12/15/16; J9012T, 41KNC61XL 01/06/12 to 12/15/16; J9012U, 41XCD50S 01/06/12 to 12/15/16; J9012V, 41FNC42XL, 01/06/12 to 12/15/16; J90143, 41XCB52S 01/09/12 to 12/15/16; J90145, 41XCB57S 01/09/12 to 12/15/16; J90146, 41FNC41XL 01/09/12 to 12/15/16; J9014N, 02CK017 01/06/12 to 12/31/99; J9016G, 41XCB52S 01/09/12 to 12/15/16; J9016H, 41FNC43XL 01/09/12 to 12/15/16; J9016J 41TNC49XL 01/10/12 to 12/15/16; J9016K 41KNC60XL 01/10/12 to 12/15/16; J9020X 41XCD51S 01/10/12 to 12/15/16; J9022W 02CK017 01/10/12 to 12/31/99; J90249 41KBC17XL 01/12/12 to 12/15/16; J9026C 41XCD51S 01/11/12 to 12/15/16; J9026D 41XCC51S 01/12/12 to 12/15/16; J9026H 02CK017 01/11/12 to 12/31/99; J9028G 41XCB57S 01/13/12 to 12/15/16; J9032A 41XCD50S 01/13/12 to 12/15/16; J9032D 41KBC17XL 01/13/12 to 12/15/16; J9033P 02CK017 01/13/12 to 12/31/99; J90379 41XCC51S 01/16/12 to 12/15/16; J9037A 41FNC42XL, 01/16/12 to 12/15/16; J9038A 41KBC17XL 01/17;/12 to 12/15/16; J90390 41KNC61XL 01/17;/12 to 12/15/16; J9042C 02CK017 01/17;/12 to 12/31/99; J9044R 41XCD51S 01/18/12 to 12/15/16; J9044T 41FNC42XL, 01/18/12 to 12/15/16; J9047G 41XCD51S 01/19/12 to 12/15/16; J9047H 41FNC41XL 01/19/12 to 12/15/16; J9051P 41XCD51S 01/20/12 to 12/15/16; J9051R 41XCC51S 01/20/12 to 12/15/16; J9051T 41XCC50S 01/20/12 to 12/15/16; J9051U 41FNC41XLD 01/20/12 to 12/15/16…
- Recall started
- April 12, 2013
- Device type
- Applier, Surgical, Clip
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Ethicon sent an Urgent : Medical Device Recall letter dated April 30, 2013 to all primary and secondary consignees via overnight UPS to allow tracking of the receipt. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately and return affected products for credit. This credit is intended to facilitate replacement purchase. For questions contact your local representative or call Ethicon Customer Support Center at 1-877-384-4266 option 6.
- Recall number
- Z-1775-2013
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays)…
- Product
- LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360¿ in either direction. The rotating knob is located to allow for a one-handed technique.
- Quantity
- 49,357
- Codes and lots
- FNC40XL, 41, 2017-09 to 2018-01; FNC41XL, 41, 2016-12 to 2018-02; FNC41XLD, 41, 2016-12 to 2018-02; FNC42XL, 41, 2016-12 to 2018-02; FNC43XL, 41, 2016-12 to 2018-02; FNC43XLD, 41, 2017-02 to 2018-02; KBC17XL, 41, 2016-12 to 2018-2; KNC03XL, 41, 2017-02 to 2017-06; KNC03XL, 42, 2017-09 to 2017-10; KNC03XL, 43, 2017-10; KNC07XL, 41, 2017-01 to 017-05; KNC07XL, 42, 2017-09 to 2017-10; KNC09XL, 41, 2016-12 to 2018-03; KNC19XL, 41, 2017-02; KNC60XL, 41, 2016-2 2018-02; KNC61XL, 41, 2016-12 to 2018-02; TNC20XL, 41, 2017-02 to 2017-03; TNC20XL, 43, 2017-10; TNC36XL, 41, 2017-01 to 2018-03; TNC49XL, 41, 2016-12 to 2018-02; TNC69XL, 41, 2016-12 to 2017-05; TNC69XL, 43, 2017-10 to 2018-1; XCB51S, 41, 2017-01; XCB51S, 42, 2017-09 to 2017-10; XCB52S, 41, 2016-12 to 2018-02; XCB55S, 41, 2017-07; XCB55S, 42, 2017-09 to 2017-10; XCB57S, 41, 2016-12 to 2018-01; XCC50S, 41, 2016-12 to 2018-02; XCC51S, 41, 2016-12 to 2018-02; XCC53S, 41, 2016-12 to 2018-02; XCD50S, 41, 2016-12 to 2018-02; XCD51S, 41, 2016-12 to 2018-02; XCD52S, 41, 2016-12 to 2018-01; KNC35XL, 42, 2017-09 to 2017-10; XBB48B, 41, 2016-07 to 2017-01; XBB48B, 42, 2017-02 and XBB79S, 41, 2017-05 to 2017-06.
- Recall started
- April 12, 2013
- Device type
- Applier, Surgical, Clip
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Ethicon sent an Urgent : Medical Device Recall letter dated April 30, 2013 to all primary and secondary consignees via overnight UPS to allow tracking of the receipt. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately and return affected products for credit. This credit is intended to facilitate replacement purchase. For questions contact your local representative or call Ethicon Customer Support Center at 1-877-384-4266 option 6.
- Recall number
- Z-1776-2013
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320)…
- Product
- LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360¿ in either direction. The rotating knob is located to allow for a one-handed technique.
- Quantity
- 10,488
- Codes and lots
- CK017, 02, 2016-11 to 2018-03
- Recall started
- April 12, 2013
- Device type
- Applier, Surgical, Clip
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- Ethicon sent an Urgent : Medical Device Recall letter dated April 30, 2013 to all primary and secondary consignees via overnight UPS to allow tracking of the receipt. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately and return affected products for credit. This credit is intended to facilitate replacement purchase. For questions contact your local representative or call Ethicon Customer Support Center at 1-877-384-4266 option 6.
- Recall number
- Z-1777-2013
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1775-2013, Z-1776-2013, Z-1777-2013. The agency record governs; check it and the company before acting.