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Solex 7 CO Kit, Applause Custom Luer

Zoll Circulation, Inc. · Model SL-2593CO · UDI-DI 00849111075541

NCX Prescription
1
510(k) clearances
4,436
Adverse events (44 deaths)
35
Recalls
4
Facilities

Description

The Solex Catheter is a 9.3 F, 26 cm, triple infusion lumen catheter designed for placement in the superior vena cava from an insertion site in the jugular vein.

Recalls

DateFirmReason
2021-08-06ZOLL Circulation, Inc.Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06ZOLL Circulation, Inc.Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06ZOLL Circulation, Inc.Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06ZOLL Circulation, Inc.Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06ZOLL Circulation, Inc.Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06ZOLL Circulation, Inc.Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06ZOLL Circulation, Inc.Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06ZOLL Circulation, Inc.Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06ZOLL Circulation, Inc.Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06ZOLL Circulation, Inc.Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.