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.
Reported: November 9, 2016 Initiated: September 2, 2016 #Z-0331-2017
Product Description
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.
Reason for Recall
Labeling inconsistency
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 330 units in US and 1,031 units OUS
- Distribution
- Nationwide distribution
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Arrow International Inc. Units affected: 330 units in US and 1,031 units OUS.
Why was this product recalled? ▼
Labeling inconsistency
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 9, 2016. Severity: Moderate. Recall number: Z-0331-2017.
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