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U.S. Department of Health and Human Services

Class 2 Device Recall Magic3 Hydrophiliccoated Female Intermittent Catheter

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  Class 2 Device Recall Magic3 Hydrophiliccoated Female Intermittent Catheter see related information
Date Initiated by Firm July 07, 2015
Date Posted August 14, 2015
Recall Status1 Terminated 3 on July 21, 2017
Recall Number Z-2385-2015
Recall Event ID 71722
510(K)Number K000723  
Product Classification Catheter, urological - Product Code KOD
Product Magic3 Hydrophilic-coated Female Intermittent Urinary Catheters (6"), 12 Fr, (30/box), Product Code 51612.

Intermittent catheter.
Code Information Lot Number 73600014, 73600079, 73600110, 73600128, 73600219
Recalling Firm/
C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Sherry Saurini
Manufacturer Reason
for Recall
Potential breach of the sterile barrier packaging.
FDA Determined
Cause 2
Unknown/Undetermined by firm
Action A recall notice was sent to consignees on 7/7/2015 asking them to discontinue use of the product. The letter to the distributors requested a sub-recall. Both letters included a response form to be returned to Bard.
Quantity in Commerce 91,140 each
Distribution Nationwide Distribution-including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI AND DC.
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 = KOD and Original Applicant = ROCHESTER MEDICAL CORP.