Z-1356-2020 Class II Terminated

Recalled by Zimmer Surgical Inc — Dover, OH

Recall Details

Product Type
Devices
Report Date
March 4, 2020
Initiation Date
January 3, 2020
Termination Date
October 30, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
58

Product Description

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.

Reason for Recall

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

Distribution Pattern

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.

Code Information

Lot 27968701