Skip to content
Recall Observatory FDA recall evidence

Device product

SMMT ambIT Kit Basic Filter Luer Cass, Product Code: 220537

Z-1686-2023

April 24, 2023

Class II

Product summary

Firm
Avanos Medical, Inc.
Event
Event 92279
Status
Terminated
Classification
Class II
Quantity
45 cases (225 cassettes)
Official record key
device-enforcement:Z-1686-2023

Official wording

Reason: Some of the ambIT kits were potentially distributed without an air in-line filter.

Code information: Lot Number (Expiration Date): 30195563 (17 Jan 2025); 30190578 (17 Jan 2025)

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Some of the ambIT kits were potentially distributed without an air in-line filter.