Recall Z-2539-2021— C.R. Bard Inc

Name: FDA recall Z-2539-2021
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. It names one FDA 510(k) clearance: K040504. Product: Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, 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

510(k) clearances named in this recall

1 on FDA's record

K040504 — BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERSC.R. Bard, Inc.·cleared 2004-05-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Catalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, 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.