Recall Z-2528-2021— C.R. Bard Inc

Name: FDA recall Z-2528-2021
Creator: U.S. Food and Drug Administration
Published: 2021-08-05

Class II · Ongoing

Class II FDA medical device recall by C.R. Bard Inc, initiated 2021-08-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device. Reason: There is potential for packaging defects that may impact the sterile barrier..

Recalling firm: C.R. Bard Inc
Classification: Class II
Status: Ongoing
Initiated: 2021-08-05
Firm location: Covington, GA, United States

Product description

Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device

Reason for recall

There is potential for packaging defects that may impact the sterile barrier.

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