FDAClass IISeptember 29, 2021

Catalog A902916 recall: Sterility Concern

Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

Why was Catalog A902916 recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog A902916, Lots: NGFR3115, UDI (01)00801741074073(17)251228(10); NGFR3278, UDI (01)00801741074073(17)251228(10); NGFR3279, UDI (01)00801741074073(17)251228(10); NGFS1308, UDI (01)00801741074073(17)251228(10); NGFS1309, UDI (01)00801741074073(17)251228(10); and NGFS1366, UDI (01)00801741074073(17)251228(10)

Product
Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
Recalling firm
C.R. Bard Inc
Quantity
29,890 units
Distribution
US Nationwide distribution.
Recall date
September 29, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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