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U.S. Department of Health and Human Services

Class 2 Device Recall BARDEX

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  Class 2 Device Recall BARDEX see related information
Date Initiated by Firm December 18, 2015
Create Date April 08, 2016
Recall Status1 Terminated 3 on June 29, 2016
Recall Number Z-1358-2016
Recall Event ID 72922
510(K)Number K910318  
Product Classification Catheter, urological (antimicrobial) and accessories - Product Code MJC
Product BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
Code Information Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. All lot numbers produced with IFU (PK7634040) are affected.
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Rene Russo
770-784-6119
Manufacturer Reason
for Recall		 Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
FDA Determined
Cause 2		 Error in labeling
Action C. R. Bard, Inc. sent a "NOTIFICATION OF MISLABELING" letter, dated 12/18/2015 to all affected consignees. The letter identifies the product, problem, and actions to be taken by the customers.
Quantity in Commerce 1,428,000 units (total)
Distribution Distributed US (nationwide) and the countries of Canada and Australia.
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 = MJC and Original Applicant = C.R. BARD, INC.
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