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.
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: 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
- Affected units
- 1,663
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.
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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