Recall archive / FDA device enforcement
Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pack ... — FDA record Z-2516-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105
- Reason
- Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2516-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) ECVC3260, Lot Number 2021031650; 2) ECVC8105, Lot Number 2023012490 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Aug 14, 2024
- Recall initiation date
- Apr 8, 2024
- Center classification date
- Aug 7, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.