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CUSTOM 5mm SOLUTION KIT
APPLIED MEDICAL RESOURCES CORPORATION · Model K2298 · UDI-DI 30607915129485
0
510(k) clearances
508
Adverse events
7
Recalls
78
Facilities
Description
Kit Contains: CTF03, 5x100 Kii® Fios® Z-THR 6/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF12, 5x100 Kii® Fios® ADVFIX DP 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C4130, 5mmx35cm EPIX® LAPA GRASPER, 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.