FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0796-2016
- Recalling firm
- Salter Labs
- 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.
- Status
- Terminated
- Initiated
- 2016-01-05
- Posted
- 2016-02-10
- Terminated
- 2016-04-21
- 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 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.
- Quantity
- 70 units
- Distribution
- Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.
- Lot, serial or model codes
- Lot No. 083115, 090715, and 122815
- 510(k) numbers
- ["K884947"]
- PMA numbers
- not on file
- Product code
- CAF
- Firm FEI
- 1314417
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28