PlainRecalls
FDA Devices Moderate Class II Ongoing

Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device

Reported: September 29, 2021 Initiated: August 5, 2021 #Z-2521-2021

Product Description

Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, 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
10,150 units
Distribution
US Nationwide distribution.
Location
Covington, GA

Frequently Asked Questions

What product was recalled?
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device. Recalled by C.R. Bard Inc. Units affected: 10,150 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-2521-2021.