B. BRAUN MEDICAL

Activity by year

Devices registered here (1)

• Filter, Intravascular, Cardiovascular
  Product code DTK (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.3375

Recalls & enforcement

• Class IIOngoing2025-07-21
  The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
• Class IOngoing2024-08-07
  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.
• Class IIOngoing2024-06-14
  Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, un…
• Class IIOngoing2024-05-17
  The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
• Class IIOngoing2022-09-01
  Potential for leakage at the catheter hub.
• Class IITerminated2022-02-07
  Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
• Class IITerminated2020-11-23
  There is the potential for the compounding system to not immediately interrupt compounding and alert user to the presence of an air bubble exceeding 3% of the ordered volume for an ingredient. This could result in a a compounded drug that does not meet the specified accuracy ra…
• Class IITerminated2017-04-10
  B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential for some blisters to be punctured resulting in a compromised sterility barrier.
• Class IITerminated2012-12-05
  B. Braun Medical Inc. is informing our customers of a field correction previously performed to address the loss of the drug library in the Outlook Pump Models 620-100 and 620-200. This could have occurred after periods of lost DC (battery) power or out of tolerance low power. Thi…
• Class ITerminated2012-11-14
  This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on August 26, 2011 due to an issue in which the Outlook ES Safety Infusion System may halt infusion but the "RUN" Light Emitting Diodes (LEDs) on the front display continue to ad…
• Class IITerminated2012-10-31
  This notice is being provided in follow up to the field correction initiated by B. Braun Medical Inc. on 26 August, 2011 due to an issue in the Outlook ES Safety Infusion System where the Care Area can inadvertently be exited thereby removing DoseGuard dose limit protection. This…
• Class IITerminated2012-10-24
  B. Braun Medical Inc. has become aware of an issue with the Outlook ES Safety Infusion System. The key panel may fail to function as intended if the underlying circuitry fails due to intermittent contact. This issue applies specifically to the HOLD button. If this occurs, the Do…

Related

• All facilities operated by B. BRAUN MEDICAL SAS

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)