FDA Devices Moderate Class II Ongoing

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

Reported: July 6, 2022 Initiated: May 17, 2022 #Z-1288-2022

Product Description

Reason for Recall

Packaging error.

Details

Recalling Firm: Baxter Healthcare Corporation
Units Affected: 99 units
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.
Location: Deerfield, IL

Frequently Asked Questions

What product was recalled? ▼

#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED. Recalled by Baxter Healthcare Corporation. Units affected: 99 units.

Why was this product recalled? ▼

Packaging error.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on July 6, 2022. Severity: Moderate. Recall number: Z-1288-2022.