18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally
Check against the official notice below — it lists the full affected range.
Zimmer Surgical Inc. has recalled 18-inch Dual Port/Single Bladder Disposable Tourniquet Cuffs (Item 60707000300, Lot Z000002044) distributed worldwide to the United States and Canada. The medical devices, which are used by qualified medical professionals to apply pressure during surgical procedures, were found to have a defect in their Instructions For Use pamphlet—the inside pages were missing the usage instructions and warnings. A total of 61 units were affected.
The recall notice does not specify a remedy or any actions that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
Reason for recall: The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings. Distribution: Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY and Internationally to Canada. Quantity: 61 units Lot/code info: Item 60707000300, Lot Z000002044
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.