Device recall: MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01
Class II FDA enforcement event 91564. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
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
Unetixs Vascular, Inc. started this device recall on 10 Feb 2023. The firm address in the FDA record is in Warwick, RI. FDA put the recall in Class II. FDA event 91564 has 4 product records. The first FDA enforcement report date is 8 Mar 2023. 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.
Worldwide distribution - US Nationwide and Global distribution.
Recalling firm
Unetixs Vascular, Inc., Warwick, RI.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1193-2023 | MultiLab Series II 2CP & 2CP Express non-invasive vascular diagnostic device, Model Number 11996-0000-01 | 1706 units | Class II | Ongoing | 8 Mar 2023 |
| Z-1194-2023 | MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01 | 2310 units | Class II | Ongoing | 8 Mar 2023 |
| Z-1195-2023 | MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01 | 2000 units | Class II | Ongoing | 8 Mar 2023 |
| Z-1196-2023 | MultiLab Series II REVO non-invasive vascular diagnostic device, Model Number 12950-0000-01 | 984 units | Class II | Ongoing | 8 Mar 2023 |
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
- 4
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1193-2023The 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 91564. https://recallregister.com/fda/ii/91564/. 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:
Worldwide distribution - US Nationwide and Global distribution.
- What quantity of product is in FDA event 91564?
- The event has 4 product records. The first record gives this quantity:
1706 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.