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U.S. Department of Health and Human Services

Class 2 Device Recall SureStep Foley Tray System

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 Class 2 Device Recall SureStep Foley Tray Systemsee related information
Date Initiated by FirmDecember 06, 2018
Create DateFebruary 05, 2019
Recall Status1 Open3, Classified
Recall NumberZ-0800-2019
Recall Event ID 81750
510(K)NumberK910318 
Product Classification Catheter, urological (antimicrobial) and accessories - Product Code MJC
ProductBARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine.
Code Information Product Code A319418AM;  Lot NGCT1929;  Exp. Date 11/30/2018
FEI Number 1018233
Recalling Firm/
Manufacturer		 Bard Medical Division
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information ContactMark Neal
770-784-6119
Manufacturer Reason
for Recall		Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the vent on the sample port.
FDA Determined
Cause 2		Device Design
ActionBard Medical Division notified customers on about 12/06/2018 via "MEDICAL DEVICE PRODUCT NOTIFICATION" letter. Customers were instructed to examine their inventory and identify any product subject to the recall, product return is not required, and if product was further distributed or transferred to notify those customers and include a copy of the medical device communication letter provided. Questions can be directed to Customer Service at 1-800-526-4455 or BMD.FieldAction@crbard.com.
Quantity in Commerce450 units
DistributionUS Nationwide Distribution io KY, NE, GA, FL, MS, IN, IL, VA, OK, TX, NM, IL, VA, PA, CA, NV.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MJC
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