Infusomat Space Pump Administration Set Recalled for Inverted Anti-Free Flow Clip
B. Braun Medical is recalling the Infusomat Space Volumetric Pump Administration Set due to a defect where the anti-free flow clip may be inverted, potentially causing unintended medication flow. No injuries have been reported.
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: This is an FDA Class II recall with a potential design defect (inverted anti-free flow clip) that could result in unintended medication administration. However, no injuries or illnesses have been reported, making the hazard theoretical rather than confirmed.
Plain-English summary
B. Braun Medical, Inc. is recalling 36,144 units of the Infusomat Space Volumetric Pump Administration Set, Product Code 490100 (Lot Number 0061761278). The recalled products were distributed to California, Michigan, Oregon, and Utah.
The anti-free flow clip of the administration set may be installed inverted, which could allow unintended free flow of medication if a user fails to follow the on-screen prompt to close the roller clamp prior to removing the set from the pump.
No injuries or illnesses have been reported in connection with this recall. Users of the affected lot should verify that the anti-free flow clip is properly oriented and ensure the roller clamp is closed before removing the administration set from the pump. Healthcare facilities using this product should review their inventory and take appropriate steps to identify and correct any inverted clips.
The recalled product
- Product
- Infusomat Space Volumetric Pump Administration Set, Product Code 490100
- Manufacturer
- B. Braun Medical, Inc.
- Category
- Medical Device — Infusion Set
- Hazard
- Affected units
- 36,144
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 (1)
- Lot Number: 0061761278
Distribution
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 · free flow
See all →- HighSIGMA Spectrum infusion pumps recalled over defective grease on the gears
FDA (Devices) · 2026-01-28
- SevereInfusion Pump Module Bezel Repair Parts Recalled for Infusion Hazards
FDA (Devices) · 2021-08-18
- CriticalAlaris Infusion Pump Module Bezel Repair Parts Recalled for Separation Risk
FDA (Devices) · 2021-06-09
- HighCareFusion Alaris Pump Module Model 8100 Recalled for Broken Platen Elements
FDA (Devices) · 2020-08-12