Z-0796-2016Class II

T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile...

Name: Z-0796-2016 T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile...
Creator: Salter Labs
Published: 2016-01-05
License: https://open.fda.gov/license/

Salter Labs / initiated 2016-01-05 / Terminated / root cause: manufacturing process

FDA source

Salter Labs began a recall of 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... on 2016-01-05. FDA classified it as Class II and gives the reason as "Reports that the T-piece does not fit on the nebulizer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0796-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-05
Posted: 2016-02-10
Terminated: 2016-04-21
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.
Product code: CAF Nebulizer (Direct Patient Interface)
Reason for recall: Reports that the T-piece does not fit on the nebulizer.
Root cause tag: manufacturing process
FDA 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 in commerce: 70 units
Distribution: Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.
Product codes and lots: Lot No. 083115, 090715, and 122815

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0796-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0796-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-10

Product code CAF

K884947Class IIHand Held Nebulizer SystemSalter Labs / cleared 1989-02-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)