UA KIT recall: Sterility Concern
UA KIT, SKU DYKM1690A; Component No. 503581
Why was UA KIT 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: 40193489744201 (Case); 10193489744200 (Ea) Lots: 19KAA457 19LAB178 20FAB341 20IAA286 20WBC414 21CBK056 21EBG180 21HBC490 21KBB192 22ABJ687 22DBO057 22GBO519 22IBB016 22LBC924 23BBN989 23EBF212 23GBA753 23IBD142 23LBJ724 24BBI191 24FBC575 24GBX259
- Product
- UA KIT, SKU DYKM1690A; 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)