Device product
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.
Z-0331-2017
Product summary
- Event
- Event 75372
- Status
- Terminated
- Classification
- Class II
- Quantity
- 330 units in US and 1,031 units OUS
- Official record key
device-enforcement:Z-0331-2017
Official wording
Reason: Labeling inconsistency
Code information: Lot # 16F15C0114, 16F15D0003, 16F15A0072, 16F15F0031, 16F15F0090, 16F15H0037, 16F16B0001, 16F16B0014, 16F16C0056, 16F16C0079, 16F16C0109, 16F16E0004, 16F16E0030
Distribution pattern: Nationwide distribution
Derived failure modes
-
Unknown
Labeling inconsistency