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Start-Up Kit Custom Luer

Zoll Circulation, Inc. · Model CG-500D · UDI-DI 00849111075336

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

Description

6 foot tubing set including integral air trap chamber and stainless steel heat exchange coil

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.