Infusion Pump Syringe Compatibility Issue May Cause Overdose or Underdose
B Braun is recalling Perfusor Space infusion pumps due to syringe compatibility issues with Cardinal Health Monoject syringes. The incompatibility may cause overdose, underdose, therapy delays, and alarm failures.
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: FDA Class II recall for syringe pump compatibility issue with potential for serious dosing and treatment delays. Meets High severity criteria as a risk-of-harm product without reported patient injuries or illnesses.
Plain-English summary
B Braun Medical Inc is recalling the Perfusor Space Infusion Pump System (Model 8713030U) due to compatibility issues with Cardinal Health Monoject syringes. Manufacturing changes to these syringes may prevent proper recognition and compatibility with the pump.
The incompatibility may result in overdose, underdose, delays in therapy delivery, delays in occlusion alarm activation, and delays in feeding. The recall affects 14,949 units distributed nationwide in the United States and internationally to Canada.
Healthcare providers should immediately stop using Cardinal Health Monoject syringes with Perfusor Space pumps. Contact B Braun Medical Inc or consult updated product instructions for information on compatible syringe options. Patients currently receiving infusions should discuss their therapy with their healthcare provider.
The recalled product
- Product
- Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Infusion Pump
- Affected units
- 14,949
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 8713030U
- UDI-DI 4046963716745
- All Serial Numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by B Braun Medical Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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