D-0176-2017 Class II Terminated

Recalled by North American Rescue LLC. — Greer, SC

Recall Details

Product Type
Drugs
Report Date
December 14, 2016
Initiation Date
September 27, 2016
Termination Date
March 9, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
unknown

Product Description

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 Pattern

Nationwide, Australia & Switzerland

Code Information

Kit Part # 80-0213 - Kit Lot # 80-0213080816W, 80-0213071316W, 80-0213041816W, 80-0213051716W, 80-0213050516W, 80-0213050916W, 80-0213081116W, 80-0213081716W, 80-0213082516W, 80-0213090216W, 80-0213090916W, 80-0213070716W, 80-0213080316W, 80-0213080116W, 80-0213072716W, 80-0213090916W; Kit Part # 80-0299 - Kit Lot # 80-0299080916W, 80-0299071116W, 80-0299060116W, 80-0299051916W, 80-0299081716W, 80-0299050316W, 80-0299051016W, 80-0299082216W; 80-0299082416W, 80-0299090616W, 80-0299090716W, 80-0299090716W, 80-0299080416W; Kit Part # 80-0298 - Kit Lot # 80-0298081116W, 80-0298060116W, 80-0298062316W, 80-0298090716W