The Recall Desk
HighFDA (Devices)·Z-1356-2020·Announced 2020-03-04

Zimmer Sterile Disposable Tourniquet Cuff Recalled for Bladder Leak

Zimmer Surgical Inc is recalling 58 units of sterile tourniquet cuffs because a leak between bladders may cause both to inflate or deflate simultaneously.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that poses a risk of harm to patients during surgery, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Zimmer Surgical Inc is recalling 58 units of Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, Dual Port, Dual Bladder, Item No. 60708015200. The recall is due to a defect where a leak between the bladders could cause both bladders to inflate or deflate when only one is intended to be used.

The affected product is identified by Lot 27968701 and UDI (01)00889024377547 (17)230812(10)27968701. These tourniquets are intended to be used by qualified medical professionals to exert pressure on arterial blood flow in a limb to produce a bloodless operating field.

The product was distributed worldwide, including nationwide in the United States in the states of CA, FL, IA, ID, IL, LA, MA, MO, NC, NY, OH, OR, PA, SC, TN, TX, WA, WI, and WV, as well as in the Netherlands. The source text does not report any injuries or illnesses associated with this defect.

The recalled product

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 prof
Affected units
58

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot 27968701

Distribution

Distributed nationwide across the United States.

The notice also names 19 states specifically: