Urine KIT W/bd CUP recall: Sterility Concern
URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
Why was Urine KIT W/bd CUP recalled?
Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
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?
UDI/DI: 40193489383707 (Case), 10193489383706 (Ea), Lots 22DBP031
- Product
- URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 626,305 Total Kits (US only)
- Distribution
- US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
- Recall date
- November 20, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)