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Recall Observatory FDA recall evidence

Device product

Catalog A942216, SureStep" Foley Tray, Bard LubricathTM, Urine Meter, StatLock" Stabilization Device

Z-2541-2021

August 05, 2021

Class II

Product summary

Firm
C.R. Bard Inc
Event
Event 88499
Status
Ongoing
Classification
Class II
Quantity
1440 units
Official record key
device-enforcement:Z-2541-2021

Official wording

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

Code information: Catalog A942216, Lot NGFS3274, UDI (01)00801741074110(17)201228(10)

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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