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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 BARDEXsee related information
Date Initiated by FirmDecember 18, 2015
Create DateApril 08, 2016
Recall Status1 Terminated 3 on June 29, 2016
Recall NumberZ-1358-2016
Recall Event ID 72922
510(K)NumberK910318 
Product Classification Catheter, urological (antimicrobial) and accessories - Product Code MJC
ProductBARDEX 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 ContactRene 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
ActionC. 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 Commerce1,428,000 units (total)
DistributionDistributed US (nationwide) and the countries of Canada and Australia.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MJC
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