Device product
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.
Z-0799-2015
Product summary
- Firm
- Teleflex Medical
- Event
- Event 69758
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,000 units
- Official record key
device-enforcement:Z-0799-2015
Official wording
Reason: Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.
Code information: Product Code: 5-10116, Lot number: 01A1400211
Distribution pattern: Worldwide Distribution -- U.S., Belgium, Canada, and Japan.
Derived failure modes
-
Unknown
Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.