Smiths Medical Recalls Bivona Cuffless FlexTend Tracheostomy Tubes Due to Packaging Error
Smiths Medical is recalling specific lots of Bivona Cuffless FlexTend Tracheostomy Tubes because they may have been packaged with the wrong neck flange, posing a risk of patient injury.
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: The recall is classified as FDA Class II and involves a risk of harm (internal or external injury) where specific injuries have not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Smiths Medical ASD Inc. is recalling 548 units of Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tubes (model 60PFS45). The recall affects lots 3991171, 3991172, and 3988103, which were distributed nationwide in the United States, including in Alabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, and Washington.
The recall was initiated because the devices may have been incorrectly packaged with a straight neck flange instead of the intended V-neck flange. This packaging error creates a potential for patient injury if an incorrect device or accessory is selected for use. The source text notes that this could lead to internal injury from excessive device contact with tissue, or external injury from device portions pressing into or rubbing against tissue.
This product is intended to provide direct airway access for tracheotomized patients for up to 29 days. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences. Consumers and healthcare providers should check their inventory for the specific model and lot numbers listed and stop using the affected devices.
The recalled product
- Product
- Tube Tracheostomy and Tube Cuff, Bivona¿ Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Usage: intended to provide direct airway access for a tracheotomized patient for up to 29 days. It ma
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 548
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 (4)
- model 60PFS45
- lots 3991171 (202 units)
- 3991172 (117 units)
- and 3988103 (229 units).
Distribution
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