FDAClass IIJuly 6, 2022

#1 MAC F/o Laryngoscope recall

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

Why was #1 MAC F/o Laryngoscope recalled?

Packaging error.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
Recalling firm
Baxter Healthcare Corporation
Quantity
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.
Recall date
July 6, 2022
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls