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Recall Observatory FDA recall evidence

Device product

Arrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.

Z-0468-2019

September 21, 2018

Class II

Product summary

Firm
Arrow International Inc
Event
Event 81242
Status
Terminated
Classification
Class II
Quantity
3640
Official record key
device-enforcement:Z-0468-2019

Official wording

Reason: The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG size .025 . For other lots in scope the lidstock correctly states the SWG size .025 however the banner card states the incorrect SWG size .032 .

Code information: Lot/Batch Numbers: 13F17E0685 13F17F0562 13F17H0141 13F17K0340 13F18B0119 13R17E0685

Distribution pattern: US Nationwide distribution in the states of CA, FL, ID, IL, MI, NC, NJ, PA, and WI.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG size .025 . For other lots in scope the lidstock correctly states the SWG size .025 however the banner card states the incorrect SWG size .032 .