Catalog A319416AM recall: Sterility Concern
Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
Why was Catalog A319416AM 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 A319416AM, Lots NGEVX107 (exp. 08/31/2022), UDI (01)00801741073861(17)201220(10); NGFR3116 (exp. 02/28/2023), UDI (01)00801741073861(17)201220(10); and NGFS1808 (02/28/2023) UDI (01)00801741073861(17)201220(10)
- Product
- Catalog A319416AM, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, Temperature Sensing, StatLock" Stabilization Device
- Recalling firm
- C.R. Bard Inc
- Quantity
- 5950 units
- Distribution
- US Nationwide distribution.
- Recall date
- September 29, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)