D-0183-2017 Class II Terminated
FDA drug recall D-0183-2017 was initiated by North American Rescue LLC. on September 27, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution. The recall status is terminated (terminated March 9, 2017). Affected quantity: unknown.
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
USCG Boat Response Kit - Product Code 80-0353, 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 # 80-0353 - Kit Lot # 80-0353051916