The Recall Desk
ModerateFDA (Devices)·Z-0845-2022·Announced 2022-04-06

BALLARD Seal Cassette Replacement catheters recalled for incorrect expiration date

Avanos Medical is recalling BALLARD Seal Cassette Replacement MAP catheter devices due to incorrect expiration dates on product labels. Affected lot 30143745 was distributed in the United States and internationally.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for incorrect expiration date labeling on sterile devices. No reported illnesses or injuries. The issue is a documentation/labeling error rather than a product defect, resulting in theoretical rather than confirmed risk.

Plain-English summary

Avanos Medical, Inc. is recalling BALLARD Seal Cassette Replacement for Multi-Access Port (MAP) Catheter devices. These sterile, single-use medical devices are packaged in cases of 20 units. The product was distributed with an incorrect expiration date.

The affected lot number is 30143745 (Finished Product Code 102008602, Alternate Code 24013-5). The product was distributed worldwide, including in Oklahoma and Ohio in the United States, and in China, France, Germany, Great Britain, Greece, Italy, and the Netherlands.

No illnesses or injuries have been reported. This FDA Class II recall was issued due to the labeling error involving the expiration date.

The recalled product

Product
BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
Manufacturer
Avanos Medical, Inc.
Category
Medical Device — Catheter Accessories
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Avanos Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Avanos Medical, Inc.

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Same hazard · labeling error

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