Perfusor Space Syringe Pump Recalled for Monoject Syringe Incompatibility Risk
B Braun's Perfusor Space infusion pump may be incompatible with Cardinal Health Monoject syringes affected by manufacturing changes, creating risks of overdose, underdose, and delayed therapy.
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 of a critical medical device with potential for serious patient harm including overdose, underdose, and treatment delays. No hospitalizations or injuries have been reported in the source material, classifying this as a risk-of-harm product where injury has not yet been documented.
Plain-English summary
This recall involves the Perfusor Space Syringe Pump (Model 8713032U), manufactured by B Braun Medical Inc. The pump is an infusion device used to administer medications and other substances. The recall affects all 4,519 units distributed with this model number.
The pump's instructions for use previously identified Monoject syringes as compatible for use. However, Cardinal Health recently changed how Monoject syringes are manufactured. These changes may prevent the pump from properly recognizing and working with the new Monoject syringes. This incompatibility could result in overdose, underdose, delays in therapy delivery, delays in feeding, and delays in occlusion alarms.
The affected pump was distributed nationwide in the United States and also to Canada. All serial numbers of Model 8713032U are involved.
If you have this pump, contact B Braun Medical Inc for guidance on whether your device is affected and what steps to take. Do not use the pump with Monoject syringes unless you receive further instruction confirming compatibility.
The recalled product
- Product
- Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each Component: N/A
- Manufacturer
- B Braun Medical Inc
- Category
- Medical Device — Infusion Pump
- Affected units
- 4,519
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 8713032U
- UDI-DI 04046964797965
- 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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