Z-1288-2022 Class II Terminated

Recalled by Baxter Healthcare Corporation — Deerfield, IL

FDA device recall Z-1288-2022 was initiated by Baxter Healthcare Corporation on May 17, 2022 and is designated Class II. Reason for recall: Packaging error. The recall status is terminated (terminated May 4, 2026). Affected quantity: 99 units.

Recall Details

Product Type
Devices
Report Date
Jul 6, 2022
Initiation Date
May 17, 2022
Termination Date
May 4, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
99 units

Product Description

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

Reason for Recall

Packaging error.

Distribution Pattern

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.

Code Information

Product Codes: 69061 (UDI/DI:732094141382), 69696 (UDI/DI: 732094141078), 69696-LED (UDI/DI: 732094230697); Lot code: 21-056

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1288-2022
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.