FDA recall Z-1433-2024

Product

Centurion STERILE ROUND EAR SPECULUM SET (3, 4, 5), Product Code I68505

Reason for recall

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

Distribution

Worldwide distribution - US Nationwide and the countries of Panama, Canada.

Key facts

Status

Ongoing

Initiation date

2024-02-23

Report date

2024-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1433-2024