Recall Z-2972-2024— B Braun Medical Inc
Class I · Ongoing
Class I FDA medical device recall by B Braun Medical Inc, initiated 2024-08-07. It names one FDA 510(k) clearance: K191910. Product: Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U. Reason: Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected..
- Recalling firm
- B Braun Medical Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2024-08-07
- Firm location
- Breinigsville, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Reason for recall
Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.
Data sourced from openFDA. This site is unofficial and independent of the FDA.