Recall Z-0359-2025— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-10-23. FDA's recall record names no specific 510(k) clearance for this event. Product: URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581. Reason: 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..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-23
- Firm location
- Northfield, IL, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.