| Class 2 Device Recall SURESTEP | |
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 |
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 |
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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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