Recall Z-0324-2017 ยท KCY Tourniquet, Pneumatic
Stryker Sustainability Solutions
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
| Date | Sep 19, 2016 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | Stryker Sustainability Solutions sent an Customer Notification letter September 19, 2016. Customers were instructed to discontinue use of the affected products. The letter stated to follow the link below to complete the Recall Effectiveness Check Form and indicate if any devices containing expiration dates from May 2016-May 2018 remain in inventory. This form must be completed even if no affected product is found. Use the following reference number as you complete the form: [Ship to Account #] If the form indicates that any affected devices remain in inventory, a prepaid shipping label w |
| Quantity | 1,695,760 |
| Distribution | U.S. distribution nationwide. No foreign distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.