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Koala® Cables

CLINICAL INNOVATIONS, LLC · Model IPC-5012 · UDI-DI 00814247020192

HFN Prescription
1
510(k) clearances
25
Adverse events (6 deaths)
1
Recalls
15
Facilities

Description

Cables to IUP catheters: HP8040A 5mV/1350

Recalls

DateFirmReason
2008-06-16Utah Medical Products, IncPossibility of compromised package sterility prior to the expiration date.

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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.