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U.S. Department of Health and Human Services

Class 2 Device Recall SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device

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  Class 2 Device Recall SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device see related information
Date Initiated by Firm July 11, 2016
Create Date January 09, 2017
Recall Status1 Terminated 3 on October 05, 2021
Recall Number Z-0967-2017
Recall Event ID 75952
Product Classification Collector, urine, (and accessories) for indwelling catheter - Product Code KNX
Product SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
Code Information NGAQ4149
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Michel Wolfe
770-784-6220
Manufacturer Reason
for Recall		 The product contained a latex catheter instead of a silicone catheter.
FDA Determined
Cause 2		 Labeling mix-ups
Action Bard Medical sent an Urgent : Medical Device Product Recall Letter dated July 11, 2016, to all affected customers. The letter requested that they check inventory and quarantine product, and if the product had been further distributed, they need to conduct a sub-recall. The letter included a reply form to be returned. For further questions, please call (770) 784-6220.
Quantity in Commerce 2690 units
Distribution US Distribution to the states of : CA, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, NE, NV, NJ, NM, NY, OR, SC, TN, TX, UT, VA, WA
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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