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Recall Observatory FDA recall evidence

Device product

BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use

Z-0845-2022

November 22, 2021

Class II

Product summary

Firm
Avanos Medical, Inc.
Event
Event 89132
Status
Terminated
Classification
Class II
Quantity
20 devices (1 case)
Official record key
device-enforcement:Z-0845-2022

Official wording

Reason: Product was distributed with incorrect expiration date.

Code information: Finished Product Code: 102008602; Alternate Code: 24013-5; Lot No.: 30143745.

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product was distributed with incorrect expiration date.