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Recall Observatory FDA recall evidence

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

August 06, 2019

Class II

Product summary

Firm
Arrow International Inc
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

    reason.no_named_rule · v1.0.0

    Products may contain the incorrect banner card within the kit