Recall Z-1356-2020— Zimmer Surgical Inc
Class II · Terminated
Class II FDA medical device recall by Zimmer Surgical Inc, initiated 2020-01-03, terminated 2020-10-30. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to a leak between the bladders..
- Recalling firm
- Zimmer Surgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-03
- Terminated
- 2020-10-30
- Firm location
- Dover, OH, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.