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U.S. Department of Health and Human Services

Class 2 Device Recall SureStep

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 Class 2 Device Recall SureStepsee related information
Date Initiated by FirmApril 15, 2020
Create DateMay 13, 2020
Recall Status1 Terminated 3 on May 20, 2021
Recall NumberZ-1970-2020
Recall Event ID 85585
510(K)NumberK040658 
Product Classification Catheter, urological (antimicrobial) and accessories - Product Code MJC
ProductSureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
Code Information Catalog Number: A304716A UDI: 00801741104299 Lot Numbers: NGDX4745 (Exp. 03/20/2021); NGDY0567 (Exp. 03/20/2021); NGDW1548 (Exp. 11/30/2021); NGDW0234 (Exp. 11/30/2021); NGDX4088 (Exp. 11/30/2021); NGDX4704 (Exp. 11/30/2021); NGDY0568 (Exp. 11/30/2021)
FEI Number 1018233
Recalling Firm/
Manufacturer		 C.R. Bard Inc
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information ContactBD Customer Support
800-526-4455
Manufacturer Reason
for Recall		There is potential for a white paper-type residue attached to the catheter.
FDA Determined
Cause 2		Under Investigation by firm
ActionCustomer/Distributer letters were mailed on April 27, 2020 via FedEx and email. BD will request distributors to conduct a sub-recall on BDs behalf. The acknowledgement form included with the letter that is mailed or faxed back to BD will be reconciled with the customer list. BD will contact 100% of our customers that have not responded to the communication to verify acknowledgement. BD is requesting that customers and distributors discard affected unit(s). Any unit(s) that are returned to BD will be quarantined upon arrival and discarded per procedure.
Quantity in Commerce8392 units
DistributionUS Nationwide distribution including in the states of AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MO, NC, NE, NJ, NY, RI, SD, TN, TX, UT, VA, WV.
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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