Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD Recalled by Arrow International Inc Due to Labeling inconsistency
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Arrow International Inc directly.
Affected 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.
Quantity: 330 units in US and 1,031 units OUS
Why Was This Recalled?
Labeling inconsistency
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Arrow International Inc
Arrow International Inc has 431 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report