Class 2 Device Recall Continuous Nerve Block Needle

• Date Initiated by Firm: February 17, 2005
• Date Posted: June 01, 2005
• Recall Status: Terminated on May 05, 2006
• Recall Number: Z-0852-05
• Recall Event ID: 31215
• 510(K)Number: K021567
• Product Classification: Anesthesia Conduction Kit - Product Code CAZ
• Product: Arrow Continuous Nerve Block Needle, Latex-Free* Rx only*Sterile*Arrow International Inc., 2400 Bernville, Road, Reading, PA 19605 USA
• Code Information: Product #AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18040-N, AB-18080-N, AB-18110-N, AB-18140-N, AB-19604-K, AB-19604-S, AB-19608-K, AB-19608-S, AB-20604-K, AB-20604-S, AB-20608-K, AB-20608-S
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: Mr. Scott Carlisle; 336-498-4153 Ext. 209
• Manufacturer Reason for Recall: Possible difficulty in passing the catheter through the needle due to a reduced ID of the needle caused by over crimping of the needle during the manufacturing process.
• FDA Determined Cause: Other
• Action: Consignees were notifed by letter on/about 02/17/2005
• Distribution: Nationwide, Africa , France, Holland, Rotterdam
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CAZ and Original Applicant = ARROW INTL., INC.