Recall Z-0967-2017— C.R. Bard, Inc.

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2016-07-11, terminated 2021-10-05. FDA's recall record names no specific 510(k) clearance for this event. Product: SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device. Reason: The product contained a latex catheter instead of a silicone catheter..

Recalling firm
C.R. Bard, Inc.
Classification
Class II
Status
Terminated
Initiated
2016-07-11
Terminated
2021-10-05
Firm location
Covington, GA, United States

Product description

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

Reason for recall

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

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