CLASS II Drug recall · Reported 14 Dec 2016 · FDA Enforcement Report
USCG Boat Response Kit - Product recalled by North American Rescue
North American Rescue is recalling USCG Boat Response Kit, distributed nationwide in the US. The recall was initiated on 27 Sep 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0183-2017
- FDA event ID
- 75415
- Recalling firm
- North American Rescue, Greer, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Sep 2016
- FDA classified
- 8 Dec 2016
- Reported
- 14 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
Timeline
| 27 Sep 2016 | Recall initiated by company | |
| 8 Dec 2016 | Classified by FDA | +72 days |
| 14 Dec 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
USCG Boat Response Kit - Product Code 80-0353, North American Rescue
Where it was distributed
Nationwide, Australia & Switzerland
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Which lots are affected?
Kit Part # 80-0353 - Kit Lot # 80-0353051916
Where was it sold?
Nationwide, Australia & Switzerland
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 75415This product is part of a recall event; the main page for the event is Advance Trauma Kit recalled by North American Rescue.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Advance Trauma Kit recalled by North American Rescue | North American Rescue | Sterility | Nationwide | |
| CLASS II | Range Trauma Kit Hardcase recalled by North American Rescue | North American Rescue | Sterility | Nationwide | |
| CLASS II | Range Trauma Kit ORG recalled by North American Rescue | North American Rescue | Sterility | Nationwide | |
| CLASS II | Aid Backpack Kit - Product recalled by North American Rescue | North American Rescue | Sterility | Nationwide | |
| CLASS II | Mini Resupply Trauma Kit - Product recalled by North American Rescue | North American Rescue | Sterility | Nationwide | |
| CLASS II | K-9 Trauma Field Kit - Product recalled by North American Rescue | North American Rescue | Sterility | Nationwide | |
| CLASS II | Range Trauma Kit - Product recalled by North American Rescue | North American Rescue | Sterility | Nationwide | |
| CLASS II | Amphibious Trauma Kit - Product recalled by North American Rescue | North American Rescue | Sterility | Nationwide |
More recalls from North American Rescue
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | AIDBAGs are first aid kits of convenience composed recalled | North American Rescue | Lead & Heavy Metals | CA, WA |
| Device | CLASS II | Junctional Emergency Treatment Tool (jett) recalled | North American Rescue | Device Malfunction | Nationwide |
| Device | CLASS II | ARS Decompression Needle recalled by North American Rescue | North American Rescue | Other | PR |
| Device | CLASS II | Flat Responder Emergency Trauma Dressing recalled | North American Rescue | Sterility | Nationwide |
| Drug | CLASS II | Amphibious Trauma Kit - Product recalled by North American Rescue | North American Rescue | Sterility | Nationwide |