Color Cuff Single Port, Single Bladder 30 (Royal Blue)… recallZ-1315-2023 · Stryker Sustainability Solutions · initiated Mar 1, 2023

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number

Z-1315-2023

Status

Open, Classified

Initiated by the company

Mar 1, 2023

Posted by the FDA

Apr 1, 2023

Recalling firm

Stryker Sustainability Solutions

Quantity

127,894

Product code

KCY

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

Product 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;

Devices named in this recall

6 devices in the FDA device registry whose identifier appears in the recall's code information.

• N/A

  Stryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC
  1 recall82 reports
• N/A

  Stryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC
  1 recall72 reports
• N/A

  Stryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC
  1 recall38 reports
• N/A

  Stryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC
  1 recall20 reports
• N/A

  Stryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC
  1 recall5 reports
• N/A

  Stryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC
  1 recall3 reports