FDA recall D-0183-2017

Product

USCG Boat Response Kit - Product Code 80-0353, 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-0183-2017