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PiCCO Catheter
Pulsion Medical Systems SE · Model PV2014L22-A · UDI-DI 04250094500979
KRB
Prescription
1
510(k) clearances
340
Adverse events (5 deaths)
4
Recalls
49
Facilities
Description
4F Thermodilution catheter, 220mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-10-05 | ICU Medical, Inc. | Potential for leakage due to defect in the thermoset check valve component. |
| 2018-10-05 | ICU Medical, Inc. | Potential for leakage due to defect in the thermoset check valve component. |
| 2018-10-05 | ICU Medical, Inc. | Potential for leakage due to defect in the thermoset check valve component. |
| 2014-11-04 | Pulsion Medical Inc | Internal testing and investigation of the packaging revealed cracks and holes in primary packaging |
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