Class 2 Device Recall Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK19608SFH

• Date Initiated by Firm: June 20, 2011
• Date Posted: November 30, 2011
• Recall Status: Terminated on October 01, 2012
• Recall Number: Z-0309-2012
• Recall Event ID: 60314
• 510(K)Number: K021567
• Product Classification: Anesthesia conduction kit - Product Code CAZ
• Product: Arrow International StimuCath(R) Continuous Nerve Block Kit, ASK-19608-SFH, Lot # MF0127039 Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia of analgesia techniques for periods not exceeding 72 hours
• Code Information: Lot number MF0127039
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Road; Reading PA 19605
• For Additional Information Contact: Tracy Larish; 610-378-0131
• Manufacturer Reason for Recall: Some of the outer trays used in the packaging of the ASK-19608-SFH Continuous Nerve Block Kits, lot # MF0127039 were found to have an insufficient seal. Therefore, the packaging may have been compromised, and sterility of the product cannot be guaranteed.
• FDA Determined Cause: Packaging
• Action: The firm, Arrow International, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 20, 2011, to its customer. The letter included a stock response form to be completed and returned to the firm. The letter also described the product, problem and action to be taken. The customer was instructed to check their stock for the products included in the scope of the recall; cease use and distribution; quarantine all affected product immediately; complete and return the enclosed Recall Acknowledgement & Stock Status Form to their sales representative, and return any affected product freight collect to: Arrow International, Inc., 312 Commerce Place, Asheboro, NC 27203, attn: Asheboro Quality Assurance Manager. Arrow International can provide replacement with a similar product or credit their account. If you have questions or concerns, please call this toll free number 800-233-3187.
• Quantity in Commerce: 17 kits
• Distribution: Nationwide distribution: CT
• 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