B. Braun Outlook ES Infusion Pumps Recalled for DoseGuard Software Defect
B. Braun Medical Inc. is expanding a field correction for Outlook ES pumps where a specific key sequence can disable dose limit protection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software defect can disable dose limit protection, creating a risk of medication error. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
B. Braun Medical Inc. is expanding a field correction for the Outlook ES Safety Infusion System. This action follows an initial field correction initiated on August 26, 2011, and adds 1,970 pumps to the recall. The affected devices are used to regulate the flow of primary and secondary fluids, including blood, lipid, and Total Parenteral Nutrition (TPN), when positive pressure is required.
The recall is due to a software issue where the Care Area can be inadvertently exited, which removes the DoseGuard dose limit protection. This occurs when a sequence of HOLD - HOLD key strokes is performed on the pump key panel while the user is in the Dose Data mode. The affected units are models 621-100ES, 621-200ES, 621-300ES, and 621-400ES with main processor software versions prior to 151580.
The affected pumps were distributed nationwide. Affected serial numbers have been notified of this field correction. Healthcare facilities should contact B. Braun Medical Inc. to arrange for the necessary software update or field correction.
The recalled product
- Product
- Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid co
- Manufacturer
- B Braun Medical, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 1,970
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model number: 621-100ES
- 621-200ES
- 621-300ES
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · B Braun Medical, Inc.
See all →- SevereB. Braun Recalls Lactated Ringer's Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-02
- ModerateB. Braun UPMC double catheter trays contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun Shands kits contain Mastisol adhesive with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
- ModerateB. Braun kits contain Mastisol adhesive with potentially cracking tubing
FDA (Devices) · 2026-06-10
Same hazard · medication error
See all →- HighIV Administration Sets from Windstone Medical for Infusion Pump Systems
FDA (Devices) · 2026-04-29
- HighMedline Industries IV Administration and Extension Sets Recalled Due to Potential Leaks
FDA (Devices) · 2026-02-25
- HighBD Pyxis Medication Dispensing Systems Software Sync Error Recall
FDA (Devices) · 2025-03-26
- ModeratePrescription statin LIVALO tablets recalled due to foreign tablets in bottles
FDA (Drugs) · 2025-03-19
- HighPyxis Medication and Anesthesia Dispensing Systems Recalled for Software Vulnerabilities
FDA (Devices) · 2025-02-19