Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of bl
Check against the official notice below — it lists the full affected range.
Stryker Corporation is recalling 16,380 Color Cuff Disposable Tourniquet Cuffs (18 inch X 3 inch, Product Number 5921-018-135) distributed worldwide because the cuffs may leak air, which could result in a loss of vascular occlusion during medical procedures. The affected products were distributed across numerous U.S. states and in Argentina, Australia, Canada, and the Netherlands, with lot numbers 60180348 and 60180373.
The recall notice does not specify a remedy or instructions for what consumers should do with affected products.
Written by software from the official notice below. Not reviewed by a lawyer.
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
Reason for recall: There is a potential for the cuff to leak air leading to a loss of vascular occlusion. Distribution: Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands. Quantity: 16,380 total Lot/code info: GTIN: 37613154599258, Lot Numbers 60180348, 60180373
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.