Device product
8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue¿ permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard¿ technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard¿ antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Z-2555-2019
Product summary
- Event
- Event 83593
- Status
- Terminated
- Classification
- Class II
- Quantity
- 520 eaches
- Official record key
device-enforcement:Z-2555-2019
Official wording
Reason: Products may contain the incorrect banner card within the kit
Code information: Lot Number: 13F18H0610
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Products may contain the incorrect banner card within the kit