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Marina Medical
MARINA MEDICAL INSTRUMENTS, INC. · Model 800-201C · UDI-DI 00840306835254
10
510(k) clearances
1,045
Adverse events (1 deaths)
24
Recalls
378
Facilities
Description
Khouri style 12-hole pattern, 25 cm length, 4 mm diameter cannula, 2 mm x 4 mm hole size, non-aggressive holes, blunt tip, luer lock hub
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-03 | Sklar Instruments | Reports of various packaging issues that may result in a breach of the sterile barrier. |
| 2021-04-01 | CLINICAL LASERTHERMIA SYSTEMS AB | single use devices labeled as sterile may not have been adequately sterilized |
| 2020-01-15 | Cardinal Health 200, LLC | Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile |
| 2019-07-16 | TeDan Surgical Innovations LLC | There was incorrect raw material used in the production of the identified lot. |
| 2018-08-21 | Genicon, Inc. | There is potential for the plastic optical tip to become detached from the metal shaft. |
| 2018-08-21 | Genicon, Inc. | There is potential for the plastic optical tip to become detached from the metal shaft. |
| 2018-08-21 | Genicon, Inc. | There is potential for the plastic optical tip to become detached from the metal shaft. |
| 2018-08-21 | Genicon, Inc. | There is potential for the plastic optical tip to become detached from the metal shaft. |
| 2018-08-21 | Genicon, Inc. | There is potential for the plastic optical tip to become detached from the metal shaft. |
| 2018-08-21 | Genicon, Inc. | There is potential for the plastic optical tip to become detached from the metal shaft. |
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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.