Class 2 Device Recall Optionvf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.

• Date Initiated by Firm: July 11, 2016
• Date Posted: September 15, 2016
• Recall Status: Terminated on March 22, 2017
• Recall Number: Z-2830-2016
• Recall Event ID: 74712
• 510(K)Number: K023090
• Product Classification: Catheter, retention type, balloon - Product Code EZL
• Product: Option-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
• Code Information: Device Listing No.: D022512. CatalogNo.: FV14218. Lot No.: P1007637, P1007638, P1007461. Exp Date: 08/01/2016.
• Recalling Firm/ Manufacturer: C.R. Bard, Inc.; 8195 Industrial Blvd NE; Covington GA 30014-1497
• For Additional Information Contact: Bard Medical Division Field Assurance; 800-526-4455
• Manufacturer Reason for Recall: During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
• FDA Determined Cause: Device Design
• Action: C.R. Bard sent an Urgent - Medical Device Product Recall letter dated July 8, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm notifies customers of the recall, provides a clinical risk statement, and gives instructions regarding product disposition. Facilities are instructed to examine their inventory and quarantine any recalled product. The firm requested that customers complete the Recall & Effectiveness Check Form if product is or is not in inventory. If product was further distributed, customers should be forwarded the recall notification letter and Recall& Effectiveness Check Form. If you or the patient using these catheters has had an adverse event related to the recalled catheters, please contact Bard Medical Division Field Assurance at 1-800-526-4455 (option 5, then option 4) or via email at BMD.FieldAssurance@crbard. com.
• Quantity in Commerce: 274 units
• Distribution: US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and 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 = EZL