Z-0038-2025 Class II Ongoing
FDA device recall Z-0038-2025 was initiated by 3M Company - Health Care Business on August 14, 2024 and is designated Class II. Reason for recall: Contamination with foreign substance matter The recall status is ongoing. Affected quantity: 10,000 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2024
- Initiation Date
- August 14, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,000 units
Product Description
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Reason for Recall
Contamination with foreign substance matter
Distribution Pattern
International distribution to the country of South Korea.
Code Information
UDI/DI 10707387802223 (carton), UDI/DI 30707387802227 (each), Lot Number 33WWRRR