Clean Catch Kit recall: Sterility Concern
Clean Catch Kit, SKU DYKM1833A; Component No. 503581
Why was Clean Catch 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: 40193489240697 (Case); 10193489240696 (Ea) Lots: 19LAA531 20BAA260 21KBJ974 22JBK243 22LBJ966 23BBU789 23FBN998 23HBW916 23IBH024 24CBE580 24DBT234 24GBA986 24GBL321
- Product
- Clean Catch Kit, SKU DYKM1833A; 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)