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.
FDA Recall Z-0468-2019 · Posted None
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeFOZ
Date Initiated2018-09-21
Date Terminated2020-09-23
Product Quantity3640
Reason for Recall
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 .
Firm Action
Urgent Medical Device Notification letters dated 9/21/18 were distributed to customers.
Root Cause
Employee error
Distribution Pattern
US Nationwide distribution in the states of CA, FL, ID, IL, MI, NC, NJ, PA, and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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