Recall Z-1315-2023 ยท KCY Tourniquet, Pneumatic
Stryker Sustainability Solutions
Color Cuff Single Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-135; Color Cuff Dual Port, Single Bladder 30 (Royal Blue) Quick Connect, REF: 5921-030-235; Color Cuff Single Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-135; Color Cuff Dual Port, Single Bladder 34 (Purple), Quick Connect, REF: 5921-034-235; Color Cuff Single Por
| Date | Apr 1, 2023 (initiated Mar 1, 2023) |
| Status | Open, Classified |
| Reason | Increased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing during use, and 2) Pinched or unseated O-ring at the connection between the cuff, disposable fill line, and/or cuff hosing, which may lead to loss of vascular occlusion, which may lead to operative site blood loss, hemorrhage, or other complications. |
| Root cause | Process control |
| Action | On 3/1/23, recall notices started being distributed to customers. Customers were asked to do the following: 1) Follow the IFU and inspect for tears. Do not use the device if any damage is noted. Return the device and packaging to the recalling firm, if it is not in acceptable condition for surgery. 2) To avoid a pinched or unseated O-ring upon connection of the tourniquet cuff to the tourniquet controller, hold down the connector release on the tourniquet controller and take extra caution to ensure connection between the cuff and controller is not at an angle. 3) If a cuff does not reach or |
| Quantity | 127,894 |
| Distribution | US: WI, MD, NY, PA, WA, CO, GA, FL, OH, NC, TX, NJ, OR, MT, CA, RI, SC, NE, MI, LA, OK, SD, AL, VA, MS, WV, AZ, KY, IL, AR, ME, ND, MO, KS, HI, NH, AK, TN, IA, MN, IN, NV, MA, ID, DE, NM, WY, DC, VT, CT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.