FDAFDA · Food and drugs·Recall number Z-1356-2020
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.
Published March 4, 2020 · Recall initiated: January 3, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer Surgical Inc
- Distributor
- 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.
- Lot
- Lot 27968701
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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