FDA recall D-0179-2017

North American Rescue LLC. · Class II · drug

Product

K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, 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-0179-2017