Arrow Embolectomy Catheters: 4 French, 2 Lumen x 40cm, Product Number: W01798, 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 Recall Z-1473-2009 · Posted 2009-06-25
Advertisement
Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeDXE
Date Initiated2009-03-25
Date Terminated2010-02-01
Product Quantity6910 units (total all three products)
Reason for Recall
The inflation arm tubing may separate from the stopcock adapter.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution - USA and Panama.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement