FDA recall D-0176-2017

Product

Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, 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-0176-2017