PlainRecalls
FDA Devices Moderate Class II Ongoing

Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device

Reported: September 29, 2021 Initiated: August 5, 2021 #Z-2527-2021

Product Description

Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device

Reason for Recall

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

Details

Recalling Firm
C.R. Bard Inc
Units Affected
5950 units
Distribution
US Nationwide distribution.
Location
Covington, GA

Frequently Asked Questions

What product was recalled?
Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device. Recalled by C.R. Bard Inc. Units affected: 5950 units.
Why was this product recalled?
There is potential for packaging defects that may impact the sterile barrier.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 29, 2021. Severity: Moderate. Recall number: Z-2527-2021.