FDA Drug recall D-0180-2017
Amphibious Trauma Kit - Product Code 85-0639, North American Rescue
- FDA Drug
- Class II
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class II recall of Amphibious Trauma Kit - Product Code 85-0639, 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-0180-2017 |
| 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
Amphibious Trauma Kit - Product Code 85-0639, 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 # 85-0639 - Kit Lot # 85-0639080516, 85-0639060116, 85-0639061016, 85-0639071416, 85-0639072116, 85-0639050316…Kit Part # 85-0639 - Kit Lot # 85-0639080516, 85-0639060116, 85-0639061016, 85-0639071416, 85-0639072116, 85-0639050316, 85-0639050416, 85-0639051316, 85-0639082216, 85-0639090116, 85-0639091316 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0180-2017%22
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