FDA-Device2017-04-26Class II

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

C.R. Bard, Inc.
Hazard

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

Sold states
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.
Affected count
5030 units
Manufactured in
8195 Industrial Blvd NE, N/A, Covington, GA, United States
Products
SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1871-2017

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