Z-2555-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 2, 2019
- Initiation Date
- August 6, 2019
- Termination Date
- September 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 520 eaches
Product Description
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.
Reason for Recall
Products may contain the incorrect banner card within the kit
Distribution Pattern
US Nationwide distribution.
Code Information
Lot Number: 13F18H0610