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 ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
Lot numbers, UPCs & expiration codes
Kit Part # 80-0213 - Kit Lot # 80-0213080816W, 80-0213071316W, 80-0213041816W, 80-0213051716W, 80-0213050516W, 80-0213050916W, 80-0213081116W, 80-0213081716W, 80-0213082516W, 80-0213090216W, 80-0213090916W, 80-0213070716W, 80-0213080316W, 80-0213080116W, 80-0213072716W, 80-0213090916W; Kit Part # 80-0299 - Kit Lot # 80-0299080916W, 80-0299071116W, 80-0299060116W, 80-0299051916W, 80-0299081716W, 80-0299050316W, 80-0299051016W, 80-0299082216W; 80-0299082416W, 80-0299090616W, 80-0299090716W, 80-0299090716W, 80-0299080416W; Kit Part # 80-0298 - Kit Lot # 80-0298081116W, 80-0298060116W, 80-0298062316W, 80-0298090716W
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-0176-2017
- 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-0176-2017, 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 # 80-0213 - Kit Lot # 80-0213080816W, 80-0213071316W, 80-0213041816W, 80-0213051716W, 80-0213050516W, 80-0213050916W, 80-0213081116W, 80-0213081716W, 80-0213082516W, 80-0213090216W, 80-0213090916W, 80-0213070716W, 80-0213080316W, 80-0213080116W, 80-0213072716W, 80-0213090916W; Kit Part # 80-0299 - Kit Lot # 80-0299080916W, 80-0299071116W, 80-0299060116W, 80-0299051916W, 80-0299081716W, 80-0299050316W, 80-0299051016W, 80-0299082216W; 80-0299082416W, 80-0299090616W, 80-0299090716W, 80-0299090716W, 80-0299080416W; Kit Part # 80-0298 - Kit Lot # 80-0298081116W, 80-0298060116W, 80-0298062316W, 80-0298090716W
- Postal code
- 29650-4791
- Report date
- Dec 14, 2016
- Product type
- Drugs
- Recall number
- D-0176-2017
- 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 ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
- Distribution pattern
- Nationwide, Australia & Switzerland
- Recall initiation date
- Sep 27, 2016
- Initial firm notification
- Letter
- Center classification date
- Dec 8, 2016