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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Optionvf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only. see related information
Date Initiated by Firm July 11, 2016
Date Posted September 15, 2016
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = OPTICON MEDICAL, INC.
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