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FUJIFILM
FUJIFILM CORPORATION · Model CB-01P · UDI-DI 04547410515893
NWV
Prescription
0
510(k) clearances
509
Adverse events
7
Recalls
79
Facilities
Description
This product is intended to be used in combination with the compatible endoscopes, camera head, light source and light guide to adjust the color balance of endoscopic images at medical facilities under the management of physicians. Do not use this product for any other purposes.
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.