Recalls / Class II
Class IID-0178-2017
Product
Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
- Affected lot / code info
- Kit Part # 85-0742 Kit Lot # 85-0742071816; Kit Part # 85-0748 Kit Lot # 85-0746061016; Kit Part # 85-0745 - Kit Lot # 85-0745042516; Kit Part # 85-0639 - Kit Lot # 85-0639080516, 85-0639060116, 85-0639061016, 85-0639071416, 85-0639072116, 85-0639050316, 85-0639050416, 85-0639051316, 85-0639082216, 85-0639090116, 85-0639090716, 85-0639080116, 85-0639091316; Kit Part # 85-0744 - Kit Lot # 85-0744072516, 85-0744060916, 85-0744052516; Kit Part # 85-0741- Kit Lot # 85-0741071416
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-0178-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.