The Recall Desk
HighFDA (Devices)·Z-2435-2024·Announced 2024-07-31

Perfusor Space syringe pump recalled for Cardinal Health syringe incompatibility

B Braun is recalling Perfusor Space syringe pumps because manufacturing changes to Cardinal Health Monoject syringes may cause incompatibility, resulting in dosing errors or delayed treatment.

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 FDA Class II recall involving potential for serious patient harm including medication overdose/underdose and delays in therapy. The source text does not report any illnesses, injuries, or deaths. The hazards are described as potential outcomes ('may result in'), not confirmed harms. This places the recall in the High severity category per the rubric.

Plain-English summary

B Braun Medical Inc is recalling the Perfusor Space Syringe Pump (Model 8713080U), an infusion pump used to deliver medications and fluids. The recall affects 1,663 units distributed nationwide in the United States and Canada.

The pump's instructions previously identified Cardinal Health Monoject syringes as compatible for use. Manufacturing changes to these syringes may compromise compatibility with the pump. The manufacturer states this incompatibility may result in overdose, underdose, delays in therapy, delayed occlusion alarms, or delayed feeding.

If you are using a Perfusor Space pump with Cardinal Health Monoject syringes, discontinue use of these syringes and contact B Braun Medical Inc for compatible alternatives.

The recalled product

Product
Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A
Manufacturer
B Braun Medical Inc
Hazard
  • overdose
  • underdose
  • therapy-delay
  • alarm-delay
  • feeding-delay

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)

  • Lot Code: Model No 8713080U
  • UDI-DI 4046963915308
  • All Serial Numbers

Distribution

Distributed nationwide across the United States.