Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.
Class II FDA: Ongoing DERMASENSOR Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
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Class II FDA: Ongoing Alcon Research LLC
Medical Device Dec 3, 2025
Potential for anesthesia leakage.
Class II FDA: Ongoing Mindray DS USA, Inc. dba Mindray North America
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
Class I FDA: Ongoing Olympus Corporation of the Americas
Medical Device Dec 3, 2025
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the…
Class II FDA: Ongoing Medtronic MiniMed, Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.
Medical Device Dec 3, 2025
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class II FDA: Ongoing B Braun Medical Inc.