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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 SURESTEP see related information
Date Initiated by Firm March 09, 2017
Create Date April 20, 2017
Recall Status1 Completed
Recall Number Z-1871-2017
Recall Event ID 76775
Product Classification System, urine drainage, closed, for nonindwelling catheter, sterile - Product Code EYZ
Product SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.
Code Information Product Code: A300316A, Lot number: NGAV2400
Recalling Firm/
Manufacturer		 C.R. Bard, Inc.
8195 Industrial Blvd NE
Covington GA 30014-1497
For Additional Information Contact Michael Wolfe
770-784-6220
Manufacturer Reason
for Recall		 Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.
FDA Determined
Cause 2		 Error in labeling
Action Consignees were notified by letter on/about 03/09/2017.
Quantity in Commerce 5030 units
Distribution CA, CO, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, NE, NJ, NM, OH, OR, PA, RI, TN, TX, VA and 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.
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