The Recall Desk
ModerateFDA (Devices)·Z-0846-2022·Announced 2022-04-06

BALLARD Multi-Access Port Catheter Distributed With Incorrect Expiration Dates

Avanos Medical is recalling BALLARD Multi-Access Port Catheters because they were distributed with incorrect expiration dates on the packaging. The recall includes 6,280 devices.

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: This is an FDA Class II recall for a labeling error—incorrect expiration dates on device packaging. No deaths, injuries, or illnesses have been reported. The hazard is the use of devices with inaccurate shelf-life information, classified as a minor labeling error without documented harm.

Plain-English summary

Avanos Medical, Inc. is recalling BALLARD Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French catheters due to incorrect expiration dates on the product packaging.

The affected devices include 6,280 units across 314 cases that were distributed nationwide in Oklahoma and Ohio, as well as internationally to China, France, Germany, Great Britain, Greece, Italy, and the Netherlands. The recall covers lot numbers 20065842, 30135996, 30135999, 30137463, 30140309, 30138711, and 30141340.

Healthcare providers and patients with these devices should contact Avanos Medical for information about the recall and instructions for replacement or return of affected products.

The recalled product

Product
BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Manufacturer
Avanos Medical, Inc.
Hazard
  • labeling-error
  • expiration-date-error

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 (9)

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

Distribution

Distributed nationwide across the United States.