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Recall Observatory FDA recall evidence

Device product

Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.

Z-1823-2012

June 07, 2012

Class II

Product summary

Firm
Arrow International Inc
Event
Event 62125
Status
Terminated
Classification
Class II
Quantity
1,085
Official record key
device-enforcement:Z-1823-2012

Official wording

Reason: Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.

Code information: Lot number RF2033361

Distribution pattern: USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.