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LAP CHOLE KIT
APPLIED MEDICAL RESOURCES CORPORATION · Model K0456 · UDI-DI 30607915127115
0
510(k) clearances
509
Adverse events
7
Recalls
78
Facilities
Description
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTF33, 11x100 Kii® Fios® ZTHR 6/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.