FDA-Device2020-03-04Class II
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: 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.
Hazard
When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.
Sold states
Worldwide distribution - US Nationwide distribution in the states of CA, FL, IA, ID, IL, LA, MA, MO, NC, NY, OH, OR, PA, SC, TN, TX, WA, WI, and WV and country of Netherlands.
Affected count
58
Manufactured in
200 W Ohio Ave, N/A, Dover, OH, United States
Products
Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200, UDI (01)00889024377547 (17)230812(10)27968701 The product is a tourniquet - Product Usage: 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1356-2020More Zimmer Surgical Inc recalls
- FDA-Device2026-07-08Zimmer Surgical A.T.S. 4000 TS Tourniquet Hoses recalled for sterility breach risk
- FDA-Device2026-07-08Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A
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