Recall Z-0796-2016 ยท CAF Nebulizer (Direct Patient Interface)
Salter Labs
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.
| Date | Feb 10, 2016 (initiated Jan 5, 2016) |
| Status | Terminated |
| Reason | Reports that the T-piece does not fit on the nebulizer. |
| Root cause | Nonconforming Material/Component |
| Action | 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 f |
| Quantity | 70 units |
| Distribution | Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K884947 | HAND HELD NEBULIZER SYSTEM Salter Labs, Feb 17, 1989 |