Facility

NORTH AMERICAN RESCUE, LLC.

4 recall(s) on record — most severe on record: Class I.

Key facts

4recalls · worst Class I

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3005034064
Establishment type	Manufacture Medical Device
Location	35 TEDWALL COURT Greer, SC, US 29650
Registration status	Active · expires 2026
Parent company	NORTH AMERICAN RESCUE, LLC. (owner-operator 9070484)
Brand names	Burntec Kit

Activity by year

Recalls (4)
Inspections (2)

Devices registered here (1)

Burn Kit Without Drug
Product code OJJ (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4022

Recalls & enforcement

Class IOngoing2026-03-27
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is …
Class IIOngoing2025-07-01
Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.
Class IITerminated2021-08-27
The device includes the incorrect Instructions for Use.
Class IITerminated2020-08-21
Lack of sterility assurance of the 30-0171

FDA inspections (2)

NAI2026-03-27
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2020-01-31
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by NORTH AMERICAN RESCUE, LLC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “NORTH AMERICAN RESCUE, LLC. (FEI 3005034064) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005034064-north-american-rescue-llc/

Not open yet

Alerts for NORTH AMERICAN RESCUE, LLC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.