Summary
The FDA issued a Class II for URINE KIT, SKU DYKM1845; Component No. 503581 by MEDLINE INDUSTRIES, LP - Northfield. Reason: Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary t.
Details
Source
Device Recall
External ID
Z-0360-2025
Action Date
2024-11-20
Status
Ongoing
Category
device
Product Description
URINE KIT, SKU DYKM1845; Component No. 503581
Lot/Code Info: 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
Quantity Affected: 626,305 Total Kits (US only)
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of AL, CA, FL, GA, IL, KY, MO, MS, MT, TN, TX, VA and WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-23
Company
Northfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 242 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0360-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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