Recall Z-1288-2022
Baxter Healthcare Corporation · initiated May 17, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
#1 MAC F/O LARYNGOSCOPE; F/O Laryngoscope Set-MAC; F/O Laryngoscope Set-MAC W/LED
Codes / lots: Product Codes: 69061 (UDI/DI:732094141382), 69696 (UDI/DI: 732094141078), 69696-LED (UDI/DI: 732094230697); Lot code: 21-056
Reason for recall
Packaging error.
FDA-determined cause: Under Investigation by firm
Action taken
The firm issued a recall notification on 05/17/2022 via UPS. The letter instructs the consignee to check their inventory, contact the firm to arrange a return and replacement of mislabeled package, verify contents of all sterile packs are labeled correctly, and complete a response form. Distributors are to share the notification with end users.
Details
- Recall number
- Z-1288-2022
- Initiated
- May 17, 2022
- Terminated
- May 4, 2026
- Product code
- CCW – Laryngoscope, Rigid
- 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…
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL