Drug recall: Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue
Class II FDA enforcement event 75415. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
North American Rescue LLC. started this drug recall on 27 Sep 2016. The firm address in the FDA record is in Greer, SC. FDA put the recall in Class II. FDA event 75415 has 9 product records. The first FDA enforcement report date is 14 Dec 2016. The record gives the status Terminated, with the termination date 9 Mar 2017.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Nationwide, Australia & Switzerland
Recalling firm
North American Rescue LLC., Greer, SC.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
9 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0175-2017 | Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue | unknown | Class II | Terminated | 14 Dec 2016 |
| D-0176-2017 | Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue | unknown | Class II | Terminated | 14 Dec 2016 |
| D-0177-2017 | Range Trauma Kit - Product Code 85-1274, North American Rescue | unknown | Class II | Terminated | 14 Dec 2016 |
| D-0178-2017 | Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue | unknown | Class II | Terminated | 14 Dec 2016 |
| D-0179-2017 | K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue | unknown | Class II | Terminated | 14 Dec 2016 |
| D-0180-2017 | Amphibious Trauma Kit - Product Code 85-0639, North American Rescue | unknown | Class II | Terminated | 14 Dec 2016 |
| D-0181-2017 | Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue | unknown | Class II | Terminated | 14 Dec 2016 |
| D-0182-2017 | Aid Backpack Kit - Product Code 85-0917, North American Rescue | unknown | Class II | Terminated | 14 Dec 2016 |
| D-0183-2017 | USCG Boat Response Kit - Product Code 80-0353, North American Rescue | unknown | Class II | Terminated | 14 Dec 2016 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Drug events that started in 2016
- 288
- Share of these events in Class II
- 46%
- Product records in this event
- 9Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 27 Mar 2026 | AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits | Device | Class I | 1 |
| 1 Jul 2025 | JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits: KIT, TCCC Training- Complete (Modules | Device | Class II | 1 |
| 27 Aug 2021 | 10 ga ARS Decompression Needle, Part Number ZZ-0298 | Device | Class II | 1 |
| 21 Aug 2020 | 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged in kits labeled as follows: a) M-FAK Mini F | Device | Class II | 1 |
Official channels
- FDA enforcement report D-0175-2017The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 75415. https://recallregister.com/fda/ii/75415/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Nationwide, Australia & Switzerland
- What quantity of product is in FDA event 75415?
- The event has 9 product records. The first record gives this quantity:
unknown
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2016 have the same class?
- 46% of the 288 drug events that started in 2016 are in Class II.