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Class 2 Device Recall SURESTEP |
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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
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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
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For Additional Information Contact |
Michael Wolfe 770-784-6220
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Manufacturer Reason for Recall |
Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.
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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
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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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