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.
Recall
- Recall Number
- Z-0796-2016
- Event Number
- 73130
- Firm
- Salter Labs 2365 Camino Vida Roble
- FEI Number
- 1314417
- Product Code
- CAF
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- January 5, 2016
- Posted
- February 10, 2016
- Terminated
- April 21, 2016
- Address
- Carlsbad, CA, 92011-1505
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.
Reports that the T-piece does not fit on the nebulizer.
A customer letter dated 1/13/16 was sent to all customers who purchased the T-piece Nebulizer with in-line connectors because of reports that the T-piece does not fit on the nebulizer. The letter informs the customers that there has been no reports of interruption or delay in therapy. Customers are instructed to contact Salter Labs Customer Service at 1-800-421-0024 to arrange for the return of the product and replacement inventory. Customers are instructed to acknowledge receipt of the communication by completing the attached reply form and faxing it to the number indicated on the attached form. Customers are instructed to contact Salter Labs Customer Support at 800-421-0024 or your local Salter Labs representative to document any issues that you have encountered or to request replacement inventory.
Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.
70 units