Recall Z-0796-2016
Salter Labs · initiated January 5, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Lot No. 083115, 090715, and 122815
Reason for recall
Reports that the T-piece does not fit on the nebulizer.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-0796-2016
- Initiated
- January 5, 2016
- Posted by FDA
- February 10, 2016
- Terminated
- April 21, 2016
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Quantity
- 70 units
- Distribution
- Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.
- Recalling firm
- Salter Labs, Carlsbad, CA