Recalls / Class II
Class IID-0179-2017
Product
K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue
- Affected lot / code info
- Kit Part # 80-0211 - Kit Lot # 80-0211070616, 80-0211051316, 80-0211041816, 80-0211030216, 80-0211072216, 80-0210070716, 80-0210050416W, 80-0210072216; Kit Part # 80-0304 - Kit Lot # 80-0304041916; Kit Part # 80-0209 - Kit Lot # 80-0209082216, 80-0209051816, 80-0209051616, 80-029050316, 80-0209041916, 80-0209060316; Kit Part # 80-210 Kit Lot # 80-021007076, 80-0210050416W, 80-0210072216; Kit Part # 80-0300 - Kit Lot # 80-0300081216, 80-0300050916, 80-0300050316, 80-0300041916, 80-0300082416; Kit Part #80-0301 - Kit Lot # 80-0301042916, 80-0301050316
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-0179-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.