—#132409

Product

ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.

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 number CDC-42802-P1A, lot number 23F14A0063

Why it was recalled

Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.

Root cause (FDA determination)

Process control

Action the firm took

An urgent Medical Device Recall Notification, dated January 2, 2015, was sent to end users requesting they check their inventory and return affected product per Arrow's instructions.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Road, Reading, Pennsylvania 19605

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2015-01-02
Posted by FDA: 2015-02-10
Terminated: 2016-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #132409. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.