D-0179-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 14, 2016
- Initiation Date
- September 27, 2016
- Termination Date
- March 9, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue
Reason for Recall
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Distribution Pattern
Nationwide, Australia & Switzerland
Code Information
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