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Fisher & Paykel Healthcare

FISHER & PAYKEL HEALTHCARE LIMITED · Model 900MR049 · UDI-DI 09420012401748

JAY Prescription
10
510(k) clearances
150
Adverse events
2
Recalls
72
Facilities

Description

Hose clip

Recalls

DateFirmReason
2022-10-20CooperSurgical, Inc.Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was
2005-10-14Instrumentation Industries Incpotential for the flexible tube portion of the assembly to become brittle and break

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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.