Bivona Aire-Cuf Endotracheal Tube
Reported: November 3, 2021 Initiated: August 9, 2021 #Z-0177-2022
Product Description
Bivona Aire-Cuf Endotracheal Tube
Reason for Recall
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 7136 devices
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, KY, MA, MN, MO, NE, NJ, NY, OH, PA, SD, TN, TX, VA, WA and Hawaii. The countries of Bermuda, Canada, Germany, Denmark, Great Britain and Italy.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Bivona Aire-Cuf Endotracheal Tube. Recalled by Smiths Medical ASD Inc.. Units affected: 7136 devices.
Why was this product recalled? ▼
Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 3, 2021. Severity: Moderate. Recall number: Z-0177-2022.
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