—#81749

Product

Arrow Embolectomy Catheters: 5 French, 2 Lumen x 40cm, Product Number: W01800, Single use, Latex Free, Rx only, Arrow International, 2400 Bernville Road, Reading, PA 19605. The arterial embolectomy catheter is intended for use in removing arterial emboli.

FDA product code: DXE — Catheter, Embolectomy
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K902327
Affected lot / code info: Lot Numbers: CF8024537, CF8035837, CF8036331, CF8036759, CF8047807, CF8059710, CF8060585, CF8062240, CF8072762, CF8074445, CF7084561, CF8096988, CF8097442, CF8097705, CF8100439, CF8109029, CF8109961, CF8110887, CF8111320, CF8111840 and CF8112312.

Why it was recalled

The inflation arm tubing may separate from the stopcock adapter.

Root cause (FDA determination)

Process control

Action the firm took

Arrow International issued an "Urgent Medical Device Recall" letter dated March 25, 2009 describing proper handling of the affected device. Consignees were also instructed to complete a Recall Acknowledgement and Stock Status Form and fax to Arrow International at 1-800-343-2935. Further questions should be directed to Arrow International, Customer Service Department at 1-800-523-8446.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA and Panama.

Timeline

Recall initiated: 2009-03-25
Posted by FDA: 2009-06-25
Terminated: 2010-02-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81749. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.