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

FDA device recall Z-0796-2016 · posted 2016-02-10 · Terminated

Recall details

Recalling firm

Salter Labs

Reason for recall

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

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CAF

Quantity affected

70 units

Distribution

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

Date initiated

2016-01-05

Date posted

2016-02-10

Date terminated

2016-04-21

Location

Carlsbad, CA

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