PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: April 6, 2022 Initiated: November 22, 2021 #Z-0847-2022

Product Description

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

Reason for Recall

Product was distributed with incorrect expiration date.

Details

Recalling Firm
Avanos Medical, Inc.
Units Affected
2,520 devices (126 cases)
Distribution
Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
Location
Alpharetta, GA

Frequently Asked Questions

What product was recalled?
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use. Recalled by Avanos Medical, Inc.. Units affected: 2,520 devices (126 cases).
Why was this product recalled?
Product was distributed with incorrect expiration date.
Which agency issued this recall?
This recall was issued by the FDA Devices on April 6, 2022. Severity: Moderate. Recall number: Z-0847-2022.