Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of bloo
Check against the official notice below — it lists the full affected range.
Stryker Corporation has recalled 16,380 Color Cuff Disposable Tourniquet Cuffs (18 inch X 3 inch, model 5921-018-235) distributed nationwide across multiple U.S. states and internationally to Argentina, Australia, Canada, and the Netherlands. The cuffs were manufactured under lot numbers 60180374 and 60181194. The recall was issued because the cuffs may leak air, which could result in a loss of vascular occlusion during use.
The source document does not specify a remedy or recommended action for consumers who have obtained this product.
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: 37613154599296, Lot Numbers 60180374, 60181194
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.