Catalog A399400A recall: Sterility Concern
Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device
Why was Catalog A399400A 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 A399400A, Lot NGFR3569, UDI (01)00801741073915(17)201228(10); Lot NGFR2691, UDI (01)00801741073915(17)201228(10) Expanded 10/8/2021 adding Lot NGFR2691, UDI (01)00801741073915(17)201228(10)
- Product
- Catalog A399400A, SureStep" Foley Tray, Add-a-Foley, Complete Care", Drainage Bag, StatLock" Stabilization Device
- Recalling firm
- C.R. Bard Inc
- Quantity
- 3980 units
- Distribution
- US Nationwide distribution.
- Recall date
- September 29, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)