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U.S. Department of Health and Human Services

Class 2 Device Recall Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip

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 Class 2 Device Recall Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tipsee related information
Date Initiated by FirmAugust 24, 2015
Date PostedSeptember 03, 2015
Recall Status1 Terminated 3 on August 01, 2016
Recall NumberZ-2732-2015
Recall Event ID 72024
510(K)NumberK000723 
Product Classification Catheter, urological - Product Code KOD
ProductMagic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter
Code Information Lot Number 53621456
FEI Number 1018233
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information ContactSherry Saurini
770-784-6119
Manufacturer Reason
for Recall		Potential breach of the sterile barrier packaging.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionThe firm, Bard, sent an "URGENT: MEDICAL PRODUCT RECALL" letter dated August 20, 2015 to customers via FedEx on 8/24/2015. The letter describes the product, problem and actions to be taken. The customers were instructed to not use or further distribute any affected product; check inventory and remove any identified affected product from your shelves; complete and return the Recall and Effectiveness Check Form by September 19, 2015, even if you have used or no longer have possession of the affected product, via fax to 1-770-784-6469 or email a scanned copy to Regan.Gealy@crbard.com ( if you cannot fax or email the form, call 1-770-784-6471 and report the required information verbally); and if you have further distributed any units of the affected lot, identify your customers and notify them at once of this product recall, and return product to Bard Medical Division, 8195 Industrial Blvd., Covington, GA 30014. BMD will provide replacement product or credit for your return product. If you have any questions, please call Vice President, Quality Assurance at 770-784-6119.
Quantity in Commerce8,970 each
DistributionUS Distribution to states of:CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, and 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 = KOD
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