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CRITIKIT(TM) SP4500
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Model 680000 · UDI-DI 00886333600007
KRB
Prescription
10
510(k) clearances
340
Adverse events (5 deaths)
4
Recalls
49
Facilities
Description
CRITIKIT(TM) SP4500 consists of a banded cooling coil connected via a 40" pressure tubing and a 2-way check valve. It has a 10ml control syringe and a separate packed 3-way stopcock and 2 protective caps.
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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