Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
FDA recall notice · announced December 14, 2016 · North American Rescue
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
The product
Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue
Reason for recall
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
Notes
Distribution: Nationwide, Australia & Switzerland
Lot/code information: 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
Quantity: unknown
Status: Terminated
Products in this recall event:
- Range Trauma Kit Hardcase - Product Code 85-0889, North American Rescue (D-0175-2017)
- Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue (D-0176-2017)
- USCG Boat Response Kit - Product Code 80-0353, North American Rescue (D-0183-2017)
- Aid Backpack Kit - Product Code 85-0917, North American Rescue (D-0182-2017)
- Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue (D-0181-2017)
- K-9 Trauma Field Kit - Product Code 80-0211, 80-0304, 80-0209, 80-0210, 80-0300, 80-0301, North American Rescue (D-0179-2017)
- Range Trauma Kit - Product Code 85-1274, North American Rescue (D-0177-2017)
- Amphibious Trauma Kit - Product Code 85-0639, North American Rescue (D-0180-2017)
- Advance Trauma Kit - Product Code 85-0742, 85-0746, 85-0745, 85-0639, 85-0744, 85-0744, 85-0741, North American Rescue (D-0178-2017)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.