Class 2 Device Recall Magic3 Hydrophiliccoated Female Intermittent Catheter

• Date Initiated by Firm: July 07, 2015
• Date Posted: August 14, 2015
• Recall Status: Terminated on July 21, 2017
• Recall Number: Z-2388-2015
• Recall Event ID: 71722
• 510(K)Number: K000723
• Product Classification: Catheter, urological - Product Code KOD
• Product: Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.
• Code Information: Lot Number 53620387, 53621274, 53621279
• Recalling Firm/ Manufacturer: C.R. Bard, Inc.; 8195 Industrial Blvd NE; Covington GA 30014-1497
• For Additional Information Contact: Sherry Saurini; 770-784-6119
• Manufacturer Reason for Recall: Potential breach of the sterile barrier packaging.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: A recall notice was sent to consignees on 7/7/2015 asking them to discontinue use of the product. The letter to the distributors requested a sub-recall. Both letters included a response form to be returned to Bard.
• Quantity in Commerce: 534,972 each
• Distribution: Nationwide Distribution-including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI AND DC.
• 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 = KOD