smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
FDA device recall Z-0146-2025 · posted 2024-10-23 · Open, Classified
Recall details
- Recalling firm
- Smiths Medical ASD Inc.
- Reason for recall
- Uncertainty in the seal integrity of the sterile packaging.
- Action taken
- Smiths medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 07/18/2024 via traceable mailing. The notice explained the issue with the products, potential risk and requested the affected devices be destroyed. Distributors were directed to notify their customers by forwarding the notice. Questions - contact smithsmedical.@sedgwick.com.
- Root cause
- Packaging process control
- Status
- Open, Classified
- Product code
- BYD
- Quantity affected
- 27,971 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-07-18
- Date posted
- 2024-10-23
- Location
- Minneapolis, MN
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