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Class II: temporary or reversible health riskTerminated

North American Rescue Range Trauma Kit Recall

Range Trauma Kit - Product Code 85-1274, North American Rescue

North American Rescue LLC. · Greer, SC

Risk level
Class II
Reported by FDA
Dec 14, 2016
Recall ID
D-0177-2017
Check your lot numberHow we source this data

Summary

North American Rescue recalled Range Trauma Kit starting Sep 27, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0177-2017 on Dec 14, 2016. Reason: Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.

Product description

Range Trauma Kit - Product Code 85-1274, North American Rescue

Lot numbers, UPCs & expiration codes

Kit Part # 85-1274 - Kit Lot # 85-1274072516W

Where it was sold

Nationwide, Australia & Switzerland

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0177-2017
Classification
Class II
Status
Terminated
Recall initiated
Sep 27, 2016
FDA report date
Dec 14, 2016
Quantity
unknown
Recall type
Voluntary: Firm initiated
Recalling firm
North American Rescue LLC.

Original FDA data

Every field from FDA enforcement report D-0177-2017, exactly as published.

Show all FDA fields
City
Greer
State
SC
Status
Terminated
Country
United States
Event ID
75415
Address
35 Tedwall Ct
Code information
Kit Part # 85-1274 - Kit Lot # 85-1274072516W
Postal code
29650-4791
Report date
Dec 14, 2016
Product type
Drugs
Recall number
D-0177-2017
Classification
Class II
Recalling firm
North American Rescue LLC.
Product quantity
unknown
Termination date
Mar 9, 2017
Reason for recall
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Range Trauma Kit - Product Code 85-1274, North American Rescue
Distribution pattern
Nationwide, Australia & Switzerland
Recall initiation date
Sep 27, 2016
Initial firm notification
Letter
Center classification date
Dec 8, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0177-2017, published Dec 14, 2016. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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