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BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port...

FDA Recall #Z-0845-2022 — Class II — November 22, 2021

Recall #Z-0845-2022 Date: November 22, 2021 Classification: Class II Status: Terminated

Product Description

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

Reason for Recall

Product was distributed with incorrect expiration date.

Recalling Firm

Avanos Medical, Inc. — Alpharetta, GA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

20 devices (1 case)

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.

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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