FDA recall Z-1356-2020

Zimmer Surgical Inc · Class II · device

Product

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

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.

Key facts

Status
Terminated
Initiation date
2020-01-03
Report date
2020-03-04
Termination date
2020-10-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dover, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1356-2020