Recall archive / FDA device enforcement
Centurion procedure kits, labeled as: 1) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number ... — FDA record Z-2771-2024
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) BREAST BIOPSY KIT, Pack Number MNS6950A; 2) BREAST BIOPSY PACK, Pack number BT515A
- 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-2771-2024
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 | MNS6950A, Lot Number 2018101150; MNS6950A, Lot Number 2019022550; MNS6950A, Lot Number 2019040350; BT515A, Lot Number 2020040990; BT515A, Lot Number 2021062990; BT515A, Lot Number 2022012090; BT515A, Lot Number 2022022890; BT515A, Lot Number 2022072990; BT515A, Lot Number 2022103190; BT515A, Lot Number 2023031790; BT515A, Lot Number 2023032890; BT515A, Lot Number 2023072590; BT515A, Lot Number 2024022990; |
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.