Class 3 Device Recall

• Date Initiated by Firm: March 08, 2005
• Date Posted: April 08, 2005
• Recall Status: Terminated on May 09, 2005
• Recall Number: Z-0696-05
• Recall Event ID: 31323
• Product Classification: Introducer, Syringe Needle - Product Code KZH
• Product: Centurion brand sterile Huber needle infusion set, 20 GA x 1 inch; product EXHN010S.
• Code Information: Lots 11014, 12134 and 01105.
• FEI Number: 1824619
• Recalling Firm/ Manufacturer: Tri-State Hospital Supply Corp; 301 Catrell Dr; Howell MI 48843-1703
• For Additional Information Contact: Karen A. Kowalczyk; 517-546-5400 Ext. 1122
• Manufacturer Reason for Recall: Some of the needles in these sets are 3/4 inches in length instead of the labeled 1 inch.
• FDA Determined Cause: Other
• Action: Consignees were notified via recall letter dated March 8, 2005 and asked to retun any unused product.
• Quantity in Commerce: 1350
• Distribution: Alabama, Kentucky, Michigan, Mississippi, Missouri, North Carolina and South Carolina.
• 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.