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U.S. Department of Health and Human Services

Class 2 Device Recall Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter

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 Class 2 Device Recall Bard Magic 3 Antibacterial Hydrophilic Intermittent Cathetersee related information
Date Initiated by FirmJuly 28, 2017
Create DateOctober 11, 2018
Recall Status1 Terminated 3 on August 25, 2020
Recall NumberZ-3226-2017
Recall Event ID 78031
510(K)NumberK033477 
Product Classification Catheter Female - Product Code MJC
ProductBard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
Code Information Catalog No. 51514; Lot No. 53623024, 53623054, 53623047, 53623122; Exp Date 01/31/2020
FEI Number 1018233
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact
770-784-6120
Manufacturer Reason
for Recall		Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.
FDA Determined
Cause 2		Employee error
ActionCustomers were notified via letter on 07/28/2017. Instructions included to examine their inventory and identify affected product and notify customers if further distributed. Bard Medical Division asks that customers contact customer service at 1-800-526-4455 if any affected units do not meet their needs.
Quantity in Commerce45,270 units
DistributionDistribution to AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA.
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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