Recall archive / FDA device enforcement
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R — FDA record Z-0038-2025
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 Aug 14, 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
- 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
- Reason
- Contamination with foreign substance matter
- Classification
- Class II
- Recalling firm
- 3M Company - Health Care Business
- Quantity
- 10,000 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0038-2025
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 10707387802223 (carton), UDI/DI 30707387802227 (each), Lot Number 33WWRRR |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of South Korea.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Oct 16, 2024
- Recall initiation date
- Aug 14, 2024
- Center classification date
- Oct 9, 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.