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KIT KE069 COLE DISE
APPLIED MEDICAL RESOURCES CORPORATION · Model GK210 · UDI-DI 20607915129372
0
510(k) clearances
508
Adverse events
7
Recalls
78
Facilities
Description
Kit Contains: CTB73, 12x100 Kii SH BLD ZTHR 6/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CTB03, 5x100 Kii SH BLD ZTHR 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX CA090, DIRECT DRIVE LCA 3/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C4130, 5mmx35cm EPIX LAPA GRASPER, 10/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-03-17 | Applied Medical Resources Corp | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage. |
| 2020-03-17 | Applied Medical Resources Corp | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage. |
| 2020-03-17 | Applied Medical Resources Corp | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage. |
| 2020-03-17 | Applied Medical Resources Corp | There may be a slightly protruding rivet on the distal end of the laparoscopic grasper which has the potential for tissue to catch on it during use and lead to tissue damage. |
| 2017-04-25 | Cook Inc. | reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products |
| 2015-12-01 | JosNoe Medical, Inc. | Damage to package seals potentially compromising sterility. |
| 2013-05-01 | Applied Medical Resources Corp | Applied Medical is conducting a voluntary recall on specific lot numbers of its Epix and Direct Drive Laparoscopic Graspers. When the ratchet trigger is activated, if a great enoug |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.