FDA Enforcement
Class II
Terminated
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.
Recall: Z-0331-2017
·
Reported November 9, 2016
Enforcement
- Recall Number
- Z-0331-2017
- Event ID
- 75372
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 9, 2016
- Initiation Date
- September 2, 2016
- Classification Date
- November 2, 2016
- Termination Date
- February 20, 2020
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607, United States
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
Labeling inconsistency
Code Info
Lot # 16F15C0114, 16F15D0003, 16F15A0072, 16F15F0031, 16F15F0090, 16F15H0037, 16F16B0001, 16F16B0014, 16F16C0056, 16F16C0079, 16F16C0109, 16F16E0004, 16F16E0030
Distribution
Nationwide distribution
Quantity
330 units in US and 1,031 units OUS