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.
Z-1356-2020
Product summary
- Event
- Event 84752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 58
- Official record key
device-enforcement:Z-1356-2020
Official wording
Reason: When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.
Code information: Lot 27968701
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.
Derived failure modes
-
Unknown
When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders.