smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100/550/000
- Company
- Smiths Medical Asd Inc.
- Recall Initiated
- July 18, 2024
- Posted
- October 23, 2024
- Recall Number
- Z-0146-2025
- Quantity
- 27,971 units
- Firm Location
- Minneapolis, MN
Reason for Recall
Uncertainty in the seal integrity of the sterile packaging.
Distribution
Worldwide distribution.
Lot / Code Info
UDI/DI 35019315022405, Lot Numbers: 4122013, 4130776, 4130777
Root Cause
Packaging process control
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.
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