Z-0796-2016 Class II Terminated
FDA device recall Z-0796-2016 was initiated by Salter Labs on January 5, 2016 and is designated Class II. Reason for recall: Reports that the T-piece does not fit on the nebulizer. The recall status is terminated (terminated April 21, 2016). Affected quantity: 70 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2016
- Initiation Date
- January 5, 2016
- Termination Date
- April 21, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 70 units
Product Description
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.
Reason for Recall
Reports that the T-piece does not fit on the nebulizer.
Distribution Pattern
Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.
Code Information
Lot No. 083115, 090715, and 122815