FDA Device Intelligence
HomeDevice types › KGZ

Accessories, Catheter

FDA product code KGZ · Class 1 · General, Plastic Surgery

769
Registered devices
886
Adverse events
23
Recalls
29
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2025-10-29B Braun Medical IncPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29B Braun Medical IncPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-10-29B Braun Medical IncPotential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
2025-03-27Galt Medical CorporationDue to a potential open seal in the sterile barrier packaging .
2020-11-16Galt Medical CorporationDue to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.
2019-05-02Cook Inc.The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.
2018-05-04Vascular Solutions, Inc.The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels o
2018-05-02Galt Medical CorporationThe products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also c
2018-05-02Galt Medical CorporationThe products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also c
2018-05-02Galt Medical CorporationThe products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were introduced during a manufacturing step. Bacterial Endotoxins also c

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.