Class 3 Device Recall Epidural Needle

• Date Initiated by Firm: June 07, 2004
• Date Posted: July 31, 2004
• Recall Status: Terminated on September 21, 2004
• Recall Number: Z-1300-04
• Recall Event ID: 29463
• Product Classification: Anesthesia Conduction Kit - Product Code CAZ
• Product: ARROW EPIDURAL CATHETERIZATION KIT. Product No. MC-05001.
• Code Information: Lot No. RF4044686, expiration date 2006-09
• FEI Number: 3015859709
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: Ms. Jody Cadd; 610-378-0131 Ext. 3318
• Manufacturer Reason for Recall: The recall is due to a confirmed packaging error of the wrong epidural needle (longer than stated).
• FDA Determined Cause: Other
• Action: The recalling firm sent a recall letter to its direct accounts to notify of the recall action and that the wrong epidural needle was packaged in the kits. The letter instructed the accounts to returned the kits to the recalling firm''s Asheboro, NC facility for rework and resterilization.
• Quantity in Commerce: 270 units
• Distribution: The recalled kits with the wrong epidural needle was distributed to the following direct accounts, to the following states in TN and TX
• 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.