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Recall Observatory FDA recall evidence

Device product

3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

Z-0038-2025

August 14, 2024

Class II

Product summary

Firm
3M Company - Health Care Business
Event
Event 95273
Status
Ongoing
Classification
Class II
Quantity
10,000 units
Official record key
device-enforcement:Z-0038-2025

Official wording

Reason: Contamination with foreign substance matter

Code information: UDI/DI 10707387802223 (carton), UDI/DI 30707387802227 (each), Lot Number 33WWRRR

Distribution pattern: International distribution to the country of South Korea.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    foreign substance