FDA Drug recall D-0176-2017
Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
- FDA Drug
- Class II
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class II recall of Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue by North American Rescue, citing lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0176-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-27 |
| Published | 2016-12-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | North American Rescue |
| Distribution | US |
Product
Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
Reason
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Identifiers
| code_info | Kit Part # 80-0213 - Kit Lot # 80-0213080816W, 80-0213071316W, 80-0213041816W, 80-0213051716W, 80-0213050516W, 80-02130…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0176-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.