FDA-Device2016-11-09Class II
HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external contamination.
Arrow International Inc
Hazard
Labeling inconsistency
Sold states
Nationwide distribution
Affected count
330 units in US and 1,031 units OUS
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external contamination.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0331-2017Don't want to check this manually?
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