Smiths Medical Tracheostomy Speaking Valve Recall for Packaging Integrity Issue
Smiths Medical is recalling 27,971 Portex ORATOR speaking valves for tracheostomy tubes due to uncertainty in sterile packaging seal integrity. The affected units may not maintain sterile status, potentially exposing users to contamination.
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: This is an FDA Class II recall of a sterile medical device used in an invasive procedure. Although no injuries or illnesses have been reported, packaging seal uncertainty poses a risk of contamination to patients. This meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Smiths Medical ASD Inc. is recalling the Portex ORATOR speaking valve for tracheostomy tubes (Model REF 100/550/000) due to uncertainty in the seal integrity of the sterile packaging. A total of 27,971 units have been distributed worldwide.
The affected lot numbers are 4122013, 4130776, and 4130777 (UDI/DI 35019315022405). A compromised packaging seal could allow the sterile product to become non-sterile, potentially exposing users to contamination when the device is inserted.
Patients and healthcare providers who have received affected units should contact their supplier or Smiths Medical for instructions on replacement or return. Do not use any unit if there is visible damage to the packaging.
The recalled product
- Product
- smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 27,971
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)
- UDI/DI 35019315022405
- Lot Numbers: 4122013
- 4130776
- 4130777
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 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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