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
The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams…
Class II FDA: Ongoing DJO, LLC
Medical Device Dec 3, 2025
The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering…
Class II FDA: Ongoing Pivotal Health Solutions, 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.
Medical Device Dec 3, 2025
Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.
Class II FDA: Ongoing Foundation Medicine, 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.
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.