Recall Z-1871-2017— C.R. Bard, Inc.

Name: FDA recall Z-1871-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-09

Class II · Completed

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2017-03-09. FDA's recall record names no specific 510(k) clearance for this event. Product: SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.. Reason: Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex..

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Completed
Initiated: 2017-03-09
Firm location: Covington, GA, United States

Product description

SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.

Reason for recall

Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.

Data sourced from openFDA. This site is unofficial and independent of the FDA.