Device recall: Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product…
Class II FDA enforcement event 94890. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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…
Class II, in the words of FDA
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
B Braun Medical Inc started this device recall on 14 Jun 2024. The firm address in the FDA record is in Breinigsville, PA. FDA put the recall in Class II. FDA event 94890 has 5 product records. The first FDA enforcement report date is 31 Jul 2024. The record gives the status Ongoing.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Domestic distribution nationwide. International distribution to Canada.
Recalling firm
B Braun Medical Inc, Breinigsville, PA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
5 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2433-2024 | 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 | 14949 | Class II | Ongoing | 31 Jul 2024 |
| Z-2434-2024 | 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 | 9943 | Class II | Ongoing | 31 Jul 2024 |
| Z-2435-2024 | 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 | 1663 | Class II | Ongoing | 31 Jul 2024 |
| Z-2436-2024 | 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 | 930 | Class II | Ongoing | 31 Jul 2024 |
| Z-2437-2024 | 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 | 4519 | Class II | Ongoing | 31 Jul 2024 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 5Median of the firm: 1
- Events of the firm on the register
- 90
Other events of the firm
Official channels
- FDA enforcement report Z-2433-2024The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 94890. https://recallregister.com/fda/ii/94890/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Domestic distribution nationwide. International distribution to Canada.
- What quantity of product is in FDA event 94890?
- The event has 5 product records. The first record gives this quantity:
14949
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.