Bivona Aire-Cuf Endotracheal Tubes Recalled for Compromised Sterile Barrier
Smiths Medical is recalling 7136 Bivona Aire-Cuf Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. The issue affects specific lot numbers with 325mm shaft length.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of endotracheal tubes with a compromised sterile barrier. No reported injuries, making this a risk-of-harm scenario meeting the Score 3 criterion.
Plain-English summary
Smiths Medical ASD Inc. is recalling 7136 Bivona Aire-Cuf Endotracheal Tubes due to inadequate pouch seals on products with a shaft length of 325mm. The inadequate seal leads to a compromised sterile barrier.
The recalled devices were distributed worldwide, including in the following U.S. states: Alabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Kentucky, Massachusetts, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Dakota, Tennessee, Texas, Virginia, Washington, and Hawaii. International distribution includes Bermuda, Canada, Germany, Denmark, Great Britain, and Italy. Affected lot numbers vary by SKU.
Endotracheal tubes are critical medical devices used in respiratory care. A compromised sterile barrier could allow contamination of the device prior to patient use.
The recalled product
- Product
- Bivona Aire-Cuf Endotracheal Tube
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 7,136
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 3237504
- 3263029
- 3263030
- 3267969
- 3276517
- 3276518
- 3276519
- 3301034
- 3301035
- 3301036
- 3301479
- 3307931
- 3312816
- 3312817
- 3312818
- 3312819
- 3315710
- 3315711
- 3315712
- 3346087
Distribution
Part of a larger recall action
This product is one of 2 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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