B. Braun Recalls Outlook Safety Infusion System Burette Sets
B. Braun Medical is recalling 900 Outlook Safety Infusion System Burette Sets because one injection site and valve were assembled upside down.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with a structural assembly defect (upside-down valve) that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
B. Braun Medical, Inc. is recalling 900 units of the Outlook Safety Infusion System Burette Set (Catalog Number 375038, Lot Number 0061317318). The product is used for intravenous fluid administration. The recall was initiated after reports indicated that one of the ULTRASITE injection sites and the corresponding low pressure backcheck valve were assembled upside down.
The affected units were distributed in the states of Florida, New York, New Jersey, and Texas. The expiration date for the recalled lot is 04/30/2016.
Healthcare facilities and consumers should stop using the affected product immediately. B. Braun Medical is the recalling firm responsible for managing the recall.
The recalled product
- Product
- Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
- Manufacturer
- B. Braun Medical, Inc.
- Affected units
- 900
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)
- Catelog Number 375038
- Lot Number 0061317318
- Expiration Date: 04/30/2016
Distribution
Related recalls
Same manufacturer · B. Braun Medical, Inc.
See all →- CriticalB. Braun Recalls Sodium Chloride Injection Due to Particulate Matter
FDA (Drugs) · 2026-09-16
- LowB Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
- 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 spinal epidural kits contain Mastisol with cracking tubing
FDA (Devices) · 2026-06-10
Same hazard · assembly defect
See all →- ModerateOctopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateCardiosave battery charging station left bay screw prevents full battery insertion
FDA (Devices) · 2026-03-25
- HighMedtronic tissue stabilizer recalled after tubing was assembled in reverse
FDA (Devices) · 2026-03-04
Similar recalls
- HighOutlook IV Infusion Pump Set Recalled Due to Backcheck Valve Malfunction Risk
FDA (Devices) · 2024-07-24
- HighB. Braun Outlook Safety Infusion System Y-type Blood Set Recall for Leakage
FDA (Devices) · 2020-02-12
- HighOutlook Pump Set Infusion System Recalled for Leakage and Medication Delivery Risk
FDA (Devices) · 2021-10-06
- HighB. Braun Outlook Pump Set 3 Recalled for Leakage and Medication Delivery Delays
FDA (Devices) · 2021-10-06
- HighBlood Administration Pump Set Recalled Due to Leakage Risk
FDA (Devices) · 2021-10-06
- HighB. Braun Outlook Pump Sets recalled for potential leakage and infection risk
FDA (Devices) · 2021-10-06