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Recall Observatory FDA recall evidence

Device 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.

Z-0796-2016

January 05, 2016

Class II

Product summary

Firm
Salter Labs
Event
Event 73130
Status
Terminated
Classification
Class II
Quantity
70 units
Official record key
device-enforcement:Z-0796-2016

Official wording

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

Code information: Lot No. 083115, 090715, and 122815

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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