Recalls / Class II
Class IID-0176-2017
Product
Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Recalling firm
- Firm
- North American Rescue LLC.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 35 Tedwall Ct, N/A, Greer, South Carolina 29650-4791
Distribution
- Quantity
- unknown
- Distribution pattern
- Nationwide, Australia & Switzerland
Timeline
- Recall initiated
- 2016-09-27
- FDA classified
- 2016-12-08
- Posted by FDA
- 2016-12-14
- Terminated
- 2017-03-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0176-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.