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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 Tray see related information
Date Initiated by Firm January 27, 2022
Create Date February 24, 2022
Recall Status1 Open3, Classified
Recall Number Z-0667-2022
Recall Event ID 89288
510(K)Number K000723  
Product Classification Catheter, urological - Product Code KOD
Product BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C
Code Information Serial Number/UDI NGEWX117 (01)00801741183249(17) NGEXX133/(01)00801741183249(17) NGEY0842/(01)00801741183249(17) NGEZ1823/(01)00801741183249(17)
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
Action The 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 Commerce 1620 units
Distribution US 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 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 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) Database 510(K)s with Product Code = KOD and Original Applicant = ROCHESTER MEDICAL CORP.
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