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U.S. Department of Health and Human Services

Class 2 Device Recall Magic3

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  Class 2 Device Recall Magic3 see related information
Date Initiated by Firm October 05, 2016
Create Date November 17, 2016
Recall Status1 Terminated 3 on October 08, 2021
Recall Number Z-0600-2017
Recall Event ID 75365
510(K)Number K033477  
Product Classification Catheter, urological (antimicrobial) and accessories - Product Code MJC
Product Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile

Product Usage:
The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal end and a tapered funnel at the distal end. The outer surface of the catheter has an antibacterial and hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. It is packaged with a water sachet that is manually burst to hydrate the catheter coating at time of use. The catheters are packaged in a film-to-film pouch and are sterilized by electron beam irradiation and are distributed as a single use device. The catheter is intended for urinary bladder drainage in adult males and females requiring catheterization for management of incontinence, voiding dysfunction and surgical procedures. Efficacy of the catheter in preventing urinary tract infection during intermittent use has not been established. The device is not intended to be used as a treatment for active urinary tract infection. For urological use only; urinary catheters are intended for use for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.
Code Information Product Code: 53514, Lot number: 53622813, Exp. Date: 30Sep2017.
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Michael Wolfe
770-784-6220
Manufacturer Reason
for Recall		 Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Bard Medical sent an Urgent Medical Device Product Recall letter dated October 5, 2016 to customers The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine and quarantine and return affected inventory. Customers were asked to complete and return the accompanying Recall & Effectiveness Check Form attached.
Quantity in Commerce 10,290 units
Distribution US Nationwide Distribution in the states of: CA, FL, IL, IN, MN, MO, NC, NJ, NY, OH, OK, PA, TX and UT.
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 = ROCHESTER MEDICAL CORP.
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