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Novy

COOK INCORPORATED · Model G26822 · UDI-DI 00827002268227

MOV Prescription
5
510(k) clearances
20
Adverse events
3
Recalls
3
Facilities

Description

Modified Novy Cornual Cannulation Set

Recalls

DateFirmReason
2016-04-15Cook Inc.Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a devi
2010-01-08Cook Women'S HealthThe distal tip may separate from the catheter while the catheter is in the patient.
2010-01-08Cook Women'S HealthThe distal tip may separate from the catheter while the catheter is in the patient.

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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.