Recall archive / FDA device enforcement
KIT PEDI CRANI LAMI, Pack Number DYNJ907372A — FDA record Z-3070-2024
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 Jun 18, 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
- KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
- Reason
- A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 485 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-3070-2024
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 | UDI/DI Case 40195327060412, UDI/DI Each 10195327060411; Lot Numbers: 23ILA372, 23ILA184, 23HLB240, 23HLA567, 23HLA126, 23ELA634, 23DLA974, 23ALA995, 22JLA577, 22HLA985, 22HLA379, 22GLB224, 22GLB099, 22GLA383, 22GLA171, 22DLA615, 22CLA957, 22ALA965, 22ALA325 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: TX, IL, CA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 18, 2024
- Recall initiation date
- Jun 18, 2024
- Center classification date
- Sep 6, 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.