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Recall Observatory FDA recall evidence

Device product

Duravent Silicone Ventilation Tube. Model Number: 240075.

Z-0707-2025

November 19, 2024

Class II

Product summary

Firm
Olympus Corporation of the Americas
Event
Event 95716
Status
Ongoing
Classification
Class II
Quantity
984 units
Official record key
device-enforcement:Z-0707-2025

Official wording

Reason: Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.

Code information: Model Number: 240075. UDI: 00521925031883 (17)331015 (10)SM405666, Lot Number: SM405666. UDI: 00521925031883 (17)331015 (10)JB362646, Lot Number: JB362646.

Distribution pattern: AL, AZ, CA, IL, KY, MD, MN, MO, NC, ND, NY, OK, PA, SC, TN, TX, WA, WI. International distribution to Australia, Canada, Germany.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.