PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 4, 2020 Initiated: January 3, 2020 #Z-1356-2020

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.

Details

Recalling Firm
Zimmer Surgical Inc
Units Affected
58
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.
Location
Dover, OH

Frequently Asked Questions

What product 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.. Recalled by Zimmer Surgical Inc. Units affected: 58.
Why was this product recalled?
When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 4, 2020. Severity: Moderate. Recall number: Z-1356-2020.