Recall Z-2333-2016— C.R. Bard, Inc.
Class III · Terminated
Class III FDA medical device recall by C.R. Bard, Inc., initiated 2016-06-29, terminated 2017-12-05. FDA's recall record names no specific 510(k) clearance for this event. Product: SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device. Reason: Labeling problem.
- Recalling firm
- C.R. Bard, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-06-29
- Terminated
- 2017-12-05
- Firm location
- Covington, GA, United States
Product description
SureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
Reason for recall
Labeling problem
Data sourced from openFDA. This site is unofficial and independent of the FDA.