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 Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-135; Color Cuff Dual Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-235;
Recall
- Recall Number
- Z-1315-2023
- Event Number
- 91845
- Firm
- Stryker Sustainability Solutions
- FEI Number
- 3009350690
- Product Code
- KCY
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- March 1, 2023
- Posted
- April 1, 2023
- Address
- 1810 W Drake Dr, Tempe, AZ, 85283-4327
Description
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 Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-135; Color Cuff Dual Port, Single Bladder 18 (Red), Quick Connect, REF: 5921-218-235;
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.
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 maintain the target pressure value during initial inflation, discontinue using the cuff. 4) Distribute the recall notice internally to all users. 5) If any of the affected devices have been forwarded to additional facilities, please contact these facilities and communicate this recall to them. Please list the additional facilities within the Business Reply Form 6) Following these steps, you may continue to use the product as-is. 7) Alternatively, you may return the impacted product. It is unclear when replacements will be available. 8) Complete and return the Recall Business Reply Form. It can be returned via email to [email protected] Adverse reactions or quality problems experienced with the use of this product can be reported to the Complaint Hotline at 1-888-763-8803 or to http://www.stryker.com/productexperience Additional affected product was distributed, so additional recall notices were distributed to these associated customers beginning on 9/26/23.
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
127,894