Class 2 Device Recall Introcan Safety IV Catheter

• Date Initiated by Firm: March 19, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on September 21, 2004
• Recall Number: Z-1092-04
• Recall Event ID: 28912
• 510(K)Number: K020785 K982805
• Product Classification: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days - Product Code FOZ
• Product: Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers: Catalog Number 4253540 - Lot number 3G26258U02 Catalog Number 4253540 - Lot number 3G27258U02
• Code Information: Catalog Number is 4253540 and the lot numbers are 3G26258U02 and 3G27258U02
• Recalling Firm/ Manufacturer: Braun,B Medical Inc; 901 Marcon Blvd; Allentown PA 18109-9512
• For Additional Information Contact: Art Morse,; 610-266-0500 Ext. 2328
• Manufacturer Reason for Recall: Mislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number.
• FDA Determined Cause: Other
• Action: The recalling firm received a product complaint of a mixed 18G Catheters with 22G Catheters.
• Quantity in Commerce: 86 units
• Distribution: The affected recalling units were distributed nationwide to the following states: AZ, CA, GA, IL, IN, MD, OH, OK, OR, MA, MI, NC, NJ, NY, OR, PA, TX, UT, VA, WI
• 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 = FOZ