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U.S. Department of Health and Human Services

Class 2 Device Recall Surestep Intermittent Catheter Tray

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 Class 2 Device Recall Surestep Intermittent Catheter Traysee related information
Date Initiated by FirmJanuary 27, 2022
Create DateFebruary 24, 2022
Recall Status1 Terminated 3 on July 10, 2026
Recall NumberZ-0666-2022
Recall Event ID 89288
510(K)NumberK000723 
Product Classification Catheter, urological - Product Code KOD
ProductBARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C
Code Information Serial Number/UDI NGEWX106/(01)00801741183232(17) NGEWX143/(01)00801741183232(17) NGFQ0368/(01)00801741183232(17) NGEW9106/(01)00801741183232(17)
FEI Number 1018233
Recalling Firm/
Manufacturer		 C.R. Bard Inc
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact
770-784-6100
Manufacturer Reason
for Recall		There is a potential to leak from the catheter where it connects to the drain bag
FDA Determined
Cause 2		Under Investigation by firm
ActionThe firm initiated the recall on 01/27/2022 by letter. The letter explained the issue and the hazard and requested consignee destroy any product on hand. Distributors were directed to destroy all product on hand and to notify their customers of the recall.
Quantity in Commerce2120 units
DistributionUS Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.
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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