Skip to content
Recall Observatory FDA recall evidence

Device product

BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use

Z-0847-2022

November 22, 2021

Class II

Product summary

Firm
Avanos Medical, Inc.
Event
Event 89132
Status
Terminated
Classification
Class II
Quantity
2,520 devices (126 cases)
Official record key
device-enforcement:Z-0847-2022

Official wording

Reason: Product was distributed with incorrect expiration date.

Code information: Finished Product Code: 102007202; Alternate Code: 240168-5; Lot No.: 30135997, 30137462, 30138710, 30140310, and 30141359.

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.