Recall Z-2349-2015— Zimmer Surgical Inc
Class II · Terminated
Class II FDA medical device recall by Zimmer Surgical Inc, initiated 2015-06-24, terminated 2016-11-04. FDA's recall record names no specific 510(k) clearance for this event. Product: 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. 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. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.. Reason: The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings..
- Recalling firm
- Zimmer Surgical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-24
- Terminated
- 2016-11-04
- Firm location
- Dover, OH, United States
Product description
30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer Surgical, Inc. 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. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.
Reason for recall
The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
Data sourced from openFDA. This site is unofficial and independent of the FDA.