Device product
T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.
Z-0796-2016
Product summary
- Firm
- Salter Labs
- Event
- Event 73130
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 units
- Official record key
device-enforcement:Z-0796-2016
Official wording
Reason: Reports that the T-piece does not fit on the nebulizer.
Code information: Lot No. 083115, 090715, and 122815
Distribution pattern: Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.
Derived failure modes
-
Unknown
Reports that the T-piece does not fit on the nebulizer.