USCG Boat Response Kit — Class II drug recall D-0183-2017
Terminated recall by North American Rescue LLC., reported 2016-12-14, distributed nationwide. Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating
| Recall number | D-0183-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | North American Rescue LLC., Greer, SC, United States |
| Recall initiated | 2016-09-27 |
| Classified | 2016-12-08 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2017-03-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CH |
| Reason classes | sterility |
| Lot numbers | 80-0353051916 |
| Model numbers | 80-0353 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0183-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.