Recall archive / FDA device enforcement
Centurion procedure packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT... — FDA record Z-2773-2024
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 packs, labeled as: 1) BIOPSY TRAY-LF, Pack Number SPEC4380; 2) CIRCUMCISION TRAY, Pack Number CIT6325; 3) CIRCUMCISION/MINOR TRAY, Pack Number CIT6785A; 4) LUMBAR PUNCTURE TRAY, Pack Number PT215; 5) ULTRASOUND GUIDED PIV KIT, Pack Number MNS9580; 6) VANTEX 7FR 3L 16CM CVC BUNDLE US, Pack Number ECVC8050
- 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-2773-2024
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 | SPEC4380, Lot Number 2023092590; CIT6325, Lot Number 2023082990; CIT6785A, Lot Number 2022120190; CIT6785A, Lot Number 2023021790; CIT6785A, Lot Number 2023041290; CIT6785A, Lot Number 2023092590; PT215, Lot Number 2023082990; MNS9580, Lot Number 2023082990; ECVC8050, Lot Number 2023082990 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 4, 2024
- Recall initiation date
- Apr 8, 2024
- Center classification date
- Aug 28, 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.