—#175289

Product

Arrow AGB+ Multi-Lumen CVC Kit-catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins Product Code: CDC-42703-1A - Product Usage: The ARROWg+ard Blue PLUS catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS catheter in preventing CRBSIs compared to the original ARROWg+ard Blue catheter has not been studied.

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 Number: 13F18L0759

Why it was recalled

Arrow AGB+ Multi-Lumen CVC Kit - lidstock incorrectly states within CDC-45703-1A a catheter 20cm in length. The banner card correctly states the product is CDC-42703-1A with a catheter 16cm in length

Root cause (FDA determination)

Packaging process control

Action the firm took

Teleflex issued notification letter dated July 17, 2019 issued via FedEx 2-day mail identifies the problem, health risk and action to take: 1. If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. If you do have stock a customer service representative will contact you to arrange issuing correct labels to relabel the product. Questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2019-07-18
Terminated: 2020-11-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #175289. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.