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Terminated

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.

FDA Recall Z-0796-2016 · Posted 2016-02-10

Recalling FirmSalter Labs
Recall StatusTerminated
Product CodeCAF
Date Initiated2016-01-05
Date Terminated2016-04-21
Product Quantity70 units

Reason for Recall

Reports that the T-piece does not fit on the nebulizer.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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