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Blunt Tip Microcannula Slim Fabinject 25G38MM
FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA · Model BTC25G038BX10 BR · UDI-DI 07898915128604
GEA
Prescription
10
510(k) clearances
1,045
Adverse events (1 deaths)
24
Recalls
378
Facilities
Description
Blunt Tip Microcannula Slim Fabinject 25G 38 mm, single use sterile pack with pilot needle - box with 10 units
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.