Device recall: LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling.
Class II FDA enforcement event 87647. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are components for various cardiac kits including pressure monitoring devices and interventional imaging devices.
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 31 Mar 2021. The firm address in the FDA record is in Minneapolis, MN. FDA put the recall in Class II. FDA event 87647 has 12 product records. The first FDA enforcement report date is 28 Apr 2021. The record gives the status Terminated, with the termination date 20 Mar 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.
Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
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-1470-2021 | LogiCal Monitoring Set, Model Number DPS564898. for blood pressure monitoring and blood sampling. | 200 devices | Class II | Terminated | 28 Apr 2021 |
| Z-1471-2021 | Mark 910 LogiCal, Model Number DPS567201. for blood pressure monitoring and blood sampling. | 10 devices | Class II | Terminated | 28 Apr 2021 |
| Z-1472-2021 | Left Heart Kit, Model Number M20268. for blood pressure monitoring. | 600 devices | Class II | Terminated | 28 Apr 2021 |
| Z-1473-2021 | LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring. | 3740 devices | Class II | Terminated | 28 Apr 2021 |
| Z-1474-2021 | Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow. | 400 devices | Class II | Terminated | 28 Apr 2021 |
| Z-1475-2021 | ANGIOGRAPHIC KIT W/MX123-3MR MANIFOLD, Model Number MX1030. for use during angiography and other special procedures. | 5540 devices | Class II | Terminated | 28 Apr 2021 |
| Z-1476-2021 | Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1333MR. Stopcocks and… | 1380 units | Class II | Terminated | 28 Apr 2021 |
| Z-1477-2021 | Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model Number MX1431MR b. 1050 STOPCOCK LEFT ROTATOR, OFF HANDLE, Model Number MX1431MRL c. 700 PSI STPCK W/ ROTATOR, Model Number MX4331R. Stopcocks and manifolds used to control the direction of IV fluid flow. | 3825 units | Class II | Terminated | 28 Apr 2021 |
| Z-1478-2021 | HIGH PRESSURE TUBING, 72IN, Model Number MX152114 (Component). Stopcocks and manifolds are used to control the direction of IV fluid flow. | 275 units | Class II | Terminated | 28 Apr 2021 |
| Z-1479-2021 | HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer. | 8150 units | Class II | Terminated | 28 Apr 2021 |
| Z-1480-2021 | Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. 122 cm, REF 607281. component of extravascular blood-pressure Transducer. | 11340 units | Class II | Terminated | 28 Apr 2021 |
| Z-1481-2021 | Medex 10 IN Pressure Injector Line w/Rot (1200psi) NS. REF B1681R, component of extravascular blood-pressure Transducer. | 500 units | Class II | Terminated | 28 Apr 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 2021
- 900
- Share of these events in Class II
- 89%
- 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-1470-2021The 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 87647. https://recallregister.com/fda/ii/87647/. 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:
Distribution US nationwide including Puerto Rico, Austria, Canada, Chile, Ecuador, Hong Kong, Mexico, Slovenia, Brazil, South Africa, Colombia, and Japan.
- What quantity of product is in FDA event 87647?
- The event has 12 product records. The first record gives this quantity:
200 devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.