Device recall: Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial…
Class II FDA enforcement event 95428. Recall start date: . Status in the FDA record: Completed.
Reason for recall, in the words of FDA
The ratchet and pawl had an out of tolerance geometry which exhibited as the left bobbin would not lock.
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
Spectrum Medical Ltd. started this device recall on 13 Mar 2023. The firm address in the FDA record is in Gloucester. FDA put the recall in Class II. FDA event 95428 has 1 product record. The first FDA enforcement report date is 30 Oct 2024. The record gives the status Completed.
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.
US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma,…
Recalling firm
Spectrum Medical Ltd., Gloucester, N/A, United Kingdom.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0224-2025 | Quantum Perfusion Systems for CPB, Roller Pumps use peristaltic action to propel blood through the venous and arterial circuit tubing. Catalog Numbers: a) 51-000013-00, b) 51-000008-00 | 172 units | Class II | Completed | 30 Oct 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 2023
- 917
- Share of these events in Class II
- 88%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 19 Mar 2025 | Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or A | Device | Class II | 2 |
| 29 May 2019 | Quantum Pump Console | Device | Class I | 1 |
Official channels
- FDA enforcement report Z-0224-2025The 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 95428. https://recallregister.com/fda/ii/95428/. 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:
US Nationwide distribution including in the states of Alabama, California, Florida, Kentucky, Maine, Massachusetts, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oklahoma,…
- What quantity of product is in FDA event 95428?
- The FDA record gives this quantity:
172 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2023 have the same class?
- 88% of the 917 device events that started in 2023 are in Class II.