Smiths Medical Recalls Single Custom Tracheostomy Device for Missing Sterilization
Smiths Medical is recalling one custom tracheostomy device that was shipped without required sterilization. The device was distributed to a customer in Germany.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a medical device shipped without required sterilization, which poses a risk of infection or harm. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling a single custom-made tracheostomy device. The company determined that the device was shipped to a customer without the required sterilization process.
The recall involves one unit of the product, which is designed to be used with CADD ambulatory infusion pumps for fluid delivery. The distribution pattern indicates international distribution to Germany.
Consumers or healthcare facilities that possess this specific device should stop using it and contact Smiths Medical for instructions on how to proceed.
The recalled product
- Product
- Custom Made Tracheostomy Device The CADD Administration Sets with Flow Stop are designed to be used with a variety of CADD ambulatory infusion pumps to allow fluid delivery from an IV bag.
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 1
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 (1)
- GS025081
Distribution
Distribution scope not specified by the agency.
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