FDA recall Z-1288-2022

Product

#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED

Reason for recall

Packaging error.

Distribution

Worldwide distribution - US Nationwide and the countries of Japan, Canada, Australia, New Zealand, Spain, Brunei Darussalam, Brazil, India, Colombia, Czechia, Egypt, Turkey, South Africa, Argentina, Mexico, Congo, United Arab Emirates, El Salvador, South Korea, Germany, Cameroon, Guyana, Austria, Bahamas, Bahrain, Bangladesh, Bolivia, Chile, Costa Rica, Dominican Republic, Finland, Guatemala, Honduras, Indonesia, Italy, Kuwait, Libya, Maldives, Namibia, Netherlands, Pakistan, Peru, Philippines, Poland, Saudi Arabia, Trinidad and Tobago, Ukraine, Vietnam.

Key facts

Status

Terminated

Initiation date

2022-05-17

Report date

2022-07-06

Termination date

2026-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1288-2022