CLASS II ONGOING Device recall · Reported 31 Jul 2024 · FDA Enforcement Report
Perfusor Space Acm-kit recalled by B Braun Medical
B Braun Medical is recalling Perfusor Space Acm-kit, distributed nationwide in the US. The recall was initiated on 14 Jun 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2436-2024
- FDA event ID
- 94890
- Recalling firm
- B Braun Medical, Breinigsville, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Jun 2024
- FDA classified
- 25 Jul 2024
- Reported
- 31 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 14 Jun 2024 | Recall initiated by company | |
| 25 Jul 2024 | Classified by FDA | +41 days |
| 31 Jul 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
Where it was distributed
Domestic distribution nationwide. International distribution to Canada.
Questions about this recall
Is Perfusor Space Acm-kit recalled?
Yes. B Braun Medical recalled Perfusor Space Acm-kit on 14 Jun 2024. The recall is Class II and its status is Ongoing. Recall number Z-2436-2024.
Why was it recalled?
Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
Which lots are affected?
Lot Code: Model No 8713040U; UDI-DI 4046963687182; All Serial Numbers
Where was it sold?
Domestic distribution nationwide. International distribution to Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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