Zimmer Surgical Inc recalls Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200…

Recall date

January 3, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1356-2020

FDA classification

Class II

Brand / firm

Zimmer Surgical Inc

Sold / distributed

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.

Why it was recalled

When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.