Date Initiated by Firm |
December 18, 2015 |
Create Date |
April 08, 2016 |
Recall Status1 |
Terminated 3 on June 29, 2016 |
Recall Number |
Z-1357-2016 |
Recall Event ID |
72922 |
Product Classification |
Catheter, urological (antimicrobial) and accessories - Product Code MJC
|
Product |
BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure. |
Code Information |
Catalog numbers: 0165I108 and 065SI10; 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
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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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