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Class 2 Device Recall BARDEX |
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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
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Product Classification |
Catheter, urological (antimicrobial) and accessories - Product Code MJC
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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
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For Additional Information Contact |
Rene Russo 770-784-6119
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Manufacturer Reason for Recall |
Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
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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
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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.
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510(K) Database |
510(K)s with Product Code = MJC and Original Applicant = C.R. BARD, INC.
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