FDA recall D-0178-2017

North American Rescue LLC. · Class II · drug

Product

Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue

Reason for recall

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Distribution

Nationwide, Australia & Switzerland

Key facts

Status
Terminated
Initiation date
2016-09-27
Report date
2016-12-14
Termination date
2017-03-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Greer, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0178-2017