FDA-Device2017-01-18Class II

SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device

C.R. Bard, Inc.
Hazard

The product contained a latex catheter instead of a silicone catheter.

Sold states
US Distribution to the states of : CA, CT, FL, GA, IL, IN, KS, KY, MD, MA, MI, NE, NV, NJ, NM, NY, OR, SC, TN, TX, UT, VA, WA
Affected count
2690 units
Manufactured in
8195 Industrial Blvd NE, Covington, GA, United States
Products
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0967-2017

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