HANDS-OFF Infusion Port Thermodilution Catheter recall: Labeling Error
HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow…
Why was HANDS-OFF Infusion Port Thermodilution Catheter recalled?
Labeling inconsistency
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 16F15C0114, 16F15D0003, 16F15A0072, 16F15F0031, 16F15F0090, 16F15H0037, 16F16B0001, 16F16B0014, 16F16C0056, 16F16C0079, 16F16C0109, 16F16E0004, 16F16E0030
- Product
- HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow…
- Recalling firm
- Arrow International Inc
- Quantity
- 330 units in US and 1,031 units OUS
- Distribution
- Nationwide distribution
- Recall date
- November 9, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)