30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, 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
Check against the official notice below — it lists the full affected range.
Zimmer Surgical Inc. is recalling 330 units of its 30-inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC due to a manufacturing defect in the Instructions For Use pamphlet. The inside pages of the folded instructional pamphlet were missing critical usage instructions and warnings that medical professionals need to properly and safely operate the device. The affected units were distributed worldwide, including throughout the United States and Canada, under lot numbers Z000002535 and Z000002541.
The recall affects medical facilities and professionals who received these tourniquet cuffs. The source document does not specify a remedy or corrective action for affected consumers.
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: 330 units Lot/code info: Item 60707010500, Lot Z000002535 & Item 60707010500, Lot Z000002541.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.