Z-1356-2020 Class II Terminated
FDA device recall Z-1356-2020 was initiated by Zimmer Surgical Inc on January 3, 2020 and is designated Class II. Reason for recall: When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders. The recall status is terminated (terminated October 30, 2020). Affected quantity: 58.
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