—#167912

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.

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K993691
Affected lot / code info: Lot/Batch Numbers: 13F17E0685 13F17F0562 13F17H0141 13F17K0340 13F18B0119 13R17E0685

Why it was recalled

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 .

Root cause (FDA determination)

Employee error

Action the firm took

Urgent Medical Device Notification letters dated 9/21/18 were distributed to customers.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

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

Timeline

Recall initiated: 2018-09-21
Terminated: 2020-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #167912. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.