Urine KIT recall: Sterility Concern
URINE KIT, SKU DYKM1845; Component No. 503581
Why was Urine 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: 40193489713993 (Case), 10193489713992 (Ea), Lots 10193489713992 21GMF840 21KMA595 22AMG015 22BMH241 22CMG029 22DMI870 22FMA088 22HMH213 22JMH449 22LMH860 23CMA518 23CMG948 23DMG087 23EMH568 23GMD322 23HME585 23IMG193 23KMD763 24AMD430 24CMA930 24CMD335 24DMA485 24FMF320 24GMJ197 24IME270
- Product
- URINE KIT, SKU DYKM1845; 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)