Reported Nov 9, 2016 · Terminated
HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a…
Arrow International Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arrow International Inc · 2400 Bernville Rd · Reading, PA · 19605-9607
Is this the product you have?
- 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.
- Lot codes and dates
Lot # 16F15C011416F15D000316F15A007216F15F003116F15F009016F15H003716F16B000116F16B001416F16C005616F16C007916F16C010916F16E000416F16E0030
- Amount recalled
- 330 units in US and 1,031 units OUS
Where it was sold
- Nationwide
Why it was recalled
Labeling inconsistency
This product could cause temporary or reversible health problems — stop using it.
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