Infusion Pump Risk of Malfunction in B. Braun Perfusor Space Devices
B. Braun is recalling 6 Perfusor Space infusion pump units that may not function properly due to inadequate inspection, potentially causing incorrect medication dosing and therapy delays.
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: FDA Class II recall for a risk-of-harm medical device with no reported injuries, hospitalizations, or deaths. The defect could result in infusion accuracy errors and incorrect medication dosing, but since no actual harm has been reported, this qualifies as High severity per the rubric.
Plain-English summary
B. Braun Medical Inc is recalling 6 Perfusor Space US Version syringe infusion pumps (Catalog Number 8713030U) that were released to market without proper inspection.
The recalled units may not function as described in the product labeling. Specifically, the syringe detection and infusion accuracy mechanisms may fail, which could result in therapy delays, delivery of too much medication (overinfusion), or delivery of too little medication (underinfusion).
The affected devices were distributed to Massachusetts and Vermont. The specific serial numbers involved are 633299, 633307, 633310, 633313, 633315, and 633318.
If you possess one of these units, contact B. Braun Medical Inc immediately for further instructions. Do not use the device until you receive guidance from the manufacturer.
The recalled product
- Product
- PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Infusion Pump
- Hazard
- syringe-detection-failure
- infusion-accuracy-error
- over-infusion
- under-infusion
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 (6)
- Serial Numbers: 633299
- 633307
- 633310
- 633313
- 633315
- 633318 GUIDID: 04046963716745
Distribution
Distributed in 2 states:
- MA
- VT
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03