FDAFDA · Food and drugs·Recall number D-0180-2017
Amphibious Trauma Kit - Product Code 85-0639, North American Rescue
Published December 14, 2016 · Recall initiated: September 27, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Concerns with product sterility by the manufacturer of the eye wash irrigating solution.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- North American Rescue LLC.
- Distributor
- Nationwide, Australia & Switzerland
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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