Perfusor Space Syringe Pump Recalled Due to Monoject Syringe Incompatibility
B Braun Medical's Perfusor Space Syringe Pump may not properly recognize Cardinal Health Monoject syringes due to manufacturing changes, risking medication overdose, underdose, or 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: This is a risk-of-harm medical device where serious medication delivery errors (overdose, underdose, therapy delay) are explicitly described in the source text, but no illnesses or injuries have been reported to date. Per the severity rubric, risk-of-harm products without reported injury score 3 (High).
Plain-English summary
B Braun Medical Inc is recalling the Perfusor Space Syringe Pump, Model 8713031U. The wireless infusion pump was distributed nationwide in the United States and to Canada, affecting approximately 9,943 units.
The pump's instructions previously identified Cardinal Health Monoject syringes as an option for use. Manufacturing changes to these syringes have made them incompatible with the pump and may prevent proper recognition of the syringe.
The incompatibility may result in pump performance issues including medication overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are no longer compatible with the Perfusor Space Syringe Pump.
Anyone using the Perfusor Space Syringe Pump should be aware that Cardinal Health Monoject syringes may not work properly with the device. Consult a healthcare provider regarding compatible syringe options.
The recalled product
- Product
- Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Component: N/A
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Infusion Pump
- Affected units
- 9,943
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 8713031U
- UDI-DI 4046964797958
- 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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