—#154605

Product

Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. 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 ARROW g+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: K071538
Affected lot / code info: Product Codes ASK-45703-PRWJ1, ASK-45703-PUAB1, and ASK-45703-PUPM Lot # 13F16L0105, 23F16K0180 and 13F16L0199

Why it was recalled

Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.

Root cause (FDA determination)

Process control

Action the firm took

Arrow International mailed an Urgent Medical Device Notification Letter dated April 4, 2017, to affected customers to inform them of the issue. Customers were asked to discontinue use immediately and return product by completing the enclosed Recall Acknowledgement Form then emailing it to recalls@teleflex.com or faxing it to 1-855-419-8507. A Customer Service Representative will provide a Return Goods Authorization Number for the products' return. For questions regarding this recall call 866-246-6990.

Recalling firm

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

Distribution

Distribution pattern: US Distribution to NJ, IL, and PA

Timeline

Recall initiated: 2017-03-17
Posted by FDA: 2017-04-10
Terminated: 2020-03-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154605. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.