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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89132

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 22, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Avanos Medical, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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

Z-0845-2022
Recall number
Z-0845-2022
Initiated
November 22, 2021
Classification
Class II
Status
Terminated
Recalling firm
Avanos Medical, Inc.
Quantity
20 devices (1 case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was distributed with incorrect expiration date.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

device · product 2 of 3

BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use

Z-0846-2022
Recall number
Z-0846-2022
Initiated
November 22, 2021
Classification
Class II
Status
Terminated
Recalling firm
Avanos Medical, Inc.
Quantity
6,280 devices (314 cases)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was distributed with incorrect expiration date.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product was distributed with incorrect expiration date.

Code information

Finished Product Code: 102005202; Alternate Code: 24014-5; Lot No.: 20065842, 30135996, 30135999, 30137463, 30140309, 30138711, and 30141360.

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.

device · product 3 of 3

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

Z-0847-2022
Recall number
Z-0847-2022
Initiated
November 22, 2021
Classification
Class II
Status
Terminated
Recalling firm
Avanos Medical, Inc.
Quantity
2,520 devices (126 cases)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was distributed with incorrect expiration date.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.