D-0180-2017 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
Amphibious Trauma Kit - Product Code 85-0639, 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 # 85-0639 - Kit Lot # 85-0639080516, 85-0639060116, 85-0639061016, 85-0639071416, 85-0639072116, 85-0639050316, 85-0639050416, 85-0639051316, 85-0639082216, 85-0639090116, 85-0639091316