Recall Z-0324-2017— Stryker Sustainability Solutions
Class II · Terminated
Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2016-09-19, terminated 2017-06-01. FDA's recall record names no specific 510(k) clearance for this event. Product: Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.. Reason: Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block requiring medical intervention..
- Recalling firm
- Stryker Sustainability Solutions
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-19
- Terminated
- 2017-06-01
- Firm location
- Tempe, AZ, United States
Product description
Reprocessed Pressure Tourniquet Cuff (PTC) Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field. Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
Reason for recall
Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block requiring medical intervention.
Data sourced from openFDA. This site is unofficial and independent of the FDA.