Recalls / Class II
Class IID-0175-2017
Product
Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue
- Affected lot / code info
- Kit Part # 85-0889 - Kit Lot # 85-0889082416, 85-0889071816, 85-0889071916, 85-0889071416, 85-0889052316, 85-0889050416, 85-0889042016, 85-0889041416, 85-0889090616, 85-0889090716, 85-0889060216, 85-0889062216, 85-0889080116, 85-0889080816
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-0175-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.