CLASS II Device recall · Reported 6 Apr 2022 · FDA Enforcement Report

Ballard* Seal Cassette Replacement Map recalled by Avanos Medical

Avanos Medical is recalling Ballard* Seal Cassette Replacement Map - Ballard* Seal Cassette Replacement for, distributed nationwide in the US. The recall was initiated on 22 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFinished Product Code: 102008602; Alternate Code: 24013-5; Lot No.: 30143745.

Quantity recalled20 devices (1 case)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0845-2022
FDA event ID: 89132
Recalling firm: Avanos Medical, Alpharetta, GA
Classification: Class II
Status: Terminated
Recall initiated: 22 Nov 2021
FDA classified: 31 Mar 2022
Reported: 6 Apr 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

22 Nov 2021	Recall initiated by company
31 Mar 2022	Classified by FDA	+129 days
6 Apr 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Product was distributed with incorrect expiration date.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide Ohio Oklahoma

Questions about this recall

Is Ballard* Seal Cassette Replacement Map - Ballard* Seal Cassette Replacement for recalled?

Yes. Avanos Medical recalled Ballard* Seal Cassette Replacement Map - Ballard* Seal Cassette Replacement for on 22 Nov 2021. The recall is Class II and its status is Terminated. Recall number Z-0845-2022.

Why was it recalled?

Product was distributed with incorrect expiration date.

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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