URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
Reported: November 20, 2024 Initiated: October 23, 2024 #Z-0359-2025
Product Description
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581
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.
Details
- Recalling Firm
- MEDLINE INDUSTRIES, LP - Northfield
- Units Affected
- 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.
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 626,305 Total Kits (US only).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 20, 2024. Severity: Moderate. Recall number: Z-0359-2025.
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