Recall archive / FDA device enforcement
Centurion procedure kits labeled as: 1) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number ... — FDA record Z-2770-2024
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) BONE MARROW TRAY, Pack Number SPEC0255; 2) CT/ULTRASOUND BIOPSY, Pack Number SPEC0262; 3) FINE LACERATION KIT, Pack Number SUT17215; 4) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number DM645; 5) LACERATION TRAY, Pack Number DYNDL1159B; 6) SUTURE TRAY, Pack Number DYNDS1064B
- 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-2770-2024
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 | SPEC0255, Lot Number 2020042080: SPEC0262, Lot Number 2018111280: SUT17215, Lot Number 2020042080: DM645, Lot Number 2018111280: DM645, Lot Number 2020042080: DM645, Lot Number 2022020780: DYNDL1159B, Lot Number 2018111280: DYNDS1064B, Lot Number 2020042080 |
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.