FDAClass IISeptember 29, 2021

Catalog A119216M recall: Sterility Concern

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

Why was Catalog A119216M 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 A119216M; Lots NGFR2561, UDI (01)00801741073687(17)201228(10) and NGFS1312, UDI (01)00801741073687(17)201228(10)

Product
Catalog A119216M, SureStep" Foley Tray, Lubri-Sil", Urine Meter, Temperature Sensing Dual, StatLock" Stabilization Device
Recalling firm
C.R. Bard Inc
Quantity
10,150 units
Distribution
US Nationwide distribution.
Recall date
September 29, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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