Device recall: medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d)…
Class II FDA enforcement event 88667. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
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
Smiths Medical ASD Inc. started this device recall on 10 Mar 2020. The firm address in the FDA record is in Minneapolis, MN. FDA put the recall in Class II. FDA event 88667 has 12 product records. The first FDA enforcement report date is 20 Oct 2021. The record gives the status Terminated, with the termination date 22 Sep 2023.
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.
Austria, France, Germany, Great Britain, and Saudi Arabia
Recalling firm
Smiths Medical ASD Inc., Minneapolis, MN.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0092-2022 | medex LogiCal 5mL Closed Blood Sampling System, Model Numbers: a) MX961E181P1 b) MX961E211P1 c) MX962E211P1 d) MX96AE181P1 e) MX96AE211P1 | 17980 units | Class II | Terminated | 20 Oct 2021 |
| Z-0093-2022 | smiths medical medex HemoDraw Plus Closed Blood Sampling Set with LogiCal Pressure Monitoring System, Model Numbers: a) MX961H182P1 b) MX961H212P1 c) MX962H182P1 d) MX962H212P1 | 140 units | Class II | Terminated | 20 Oct 2021 |
| Z-0094-2022 | smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076 | 3100 units | Class II | Terminated | 20 Oct 2021 |
| Z-0095-2022 | smiths medical medex CBSS 5 ml, Antishunt proximaler Entnahmeport 60 cm, Model Number DPSHC0081 | 10620 units | Class II | Terminated | 20 Oct 2021 |
| Z-0096-2022 | smiths medical medex CBSS 5 ml, dreifach proximaler Entnahmeport 60 cm, Model number DPSHC0082 | 870 units | Class II | Terminated | 20 Oct 2021 |
| Z-0097-2022 | smiths medical medex CBSS 5 ml, einfach proximaler Entnahmeport 60 cm, Model Number DPSHC0083 | 7080 units | Class II | Terminated | 20 Oct 2021 |
| Z-0098-2022 | smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084 | 1420 units | Class II | Terminated | 20 Oct 2021 |
| Z-0099-2022 | smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090 | 20 units | Class II | Terminated | 20 Oct 2021 |
| Z-0100-2022 | smiths medical medex CBSS-5ML Antishunt set, (172/15cm), Model Number DPSHC0091 | 20800 units | Class II | Terminated | 20 Oct 2021 |
| Z-0101-2022 | smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092 | 150 units | Class II | Terminated | 20 Oct 2021 |
| Z-0102-2022 | smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093 | 13620 units | Class II | Terminated | 20 Oct 2021 |
| Z-0103-2022 | smiths medical medex CBSS-5ML, Double set, (172+15cm), Model Number DPSHC0094 | 3620 units | Class II | Terminated | 20 Oct 2021 |
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 2020
- 916
- Share of these events in Class II
- 93%
- Product records in this event
- 12Median of the firm: 1
- Events of the firm on the register
- 108
Other events of the firm
Official channels
- FDA enforcement report Z-0092-2022The 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 88667. https://recallregister.com/fda/ii/88667/. 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:
Austria, France, Germany, Great Britain, and Saudi Arabia
- What quantity of product is in FDA event 88667?
- The event has 12 product records. The first record gives this quantity:
17980 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2020 have the same class?
- 93% of the 916 device events that started in 2020 are in Class II.