Recall archive / FDA device enforcement
GS0008 2Y - Burn Pack - STL, Item Number 880082025 — FDA record Z-0070-2024
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 Sep 11, 2023. 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
- GS0008 2Y - Burn Pack - STL, Item Number 880082025
- Reason
- Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.
- Classification
- Class II
- Recalling firm
- ROi CPS LLC
- Quantity
- 103 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0070-2024
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 10194717113805, Lot Number 97289, Exp Date 2025-07-16 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Missouri
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
- Oct 11, 2023
- Recall initiation date
- Sep 11, 2023
- Center classification date
- Oct 5, 2023
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.