Class 2 Device Recall Stryker

• Date Initiated by Firm: March 01, 2023
• Date Posted: April 04, 2023
• Recall Status: Open, Classified
• Recall Number: Z-1343-2023
• Recall Event ID: 91849
• Product Classification: Tourniquet, pneumatic - Product Code KCY
• Product: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK; ; Catalog number: 5921-218-135NS
• Code Information: GTIN: 07613327606133 Lot Numbers: 2022111801 2022112903 2022121201 2022121202 2022121203 2022121204 2022121205 2022121206
• Recalling Firm/ Manufacturer: Stryker Corporation; 1941 Stryker Way; Portage MI 49002-9711
• For Additional Information Contact: SAME; 269-800-1941
• Manufacturer Reason for Recall: Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications
• FDA Determined Cause: Under Investigation by firm
• Action: Stryker issued Urgent Medical Device Recall letter dated 2/27/23 via 2-day Fedex delivery. The purpose of this letter is to inform you of an increase in reported low pressure events for specific lots of Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs and to reiterate the steps in the Instructions For Use (IFU) to mitigate the risk to achieve or maintain pressure. Letter states reason for recall, health risk and action to take: Please review all action steps below and complete the acknowledgement section (pg.3) of this letter and return by email to Instruments.recalls@stryker.com. 1. Immediately review this notification and distribute this letter internally to all users of the Color Cuff Non-Sterile Disposable Tourniquet Cuffs. 2. Follow the subsequent steps from the Instructions For Use (IFU) to mitigate the risk of the cuff not being able to achieve or maintain pressure. Following these steps, you may continue to use the product as-is. a. Prior to using the Non-Sterile Tourniquet Cuffs, please review the Safety Directives, Inspection, and Instructions sections of the IFU. To view this IFU electronically, go to https://ifu.stryker.com/XHR/129532. b. Prior to connecting the Non-Sterile Disposable Tourniquet Cuffs to the Stryker SmartPump, please review the bullet points below from pages 18-20 of the IFU for the SmartPump¿ Tourniquet System. For troubleshooting, please refer to page 28. To view this IFU electronically, go to https://ifu.stryker.com/XHR/129013. " ALWAYS monitor pneumatic connections during use, including the cuff(s) and cuff connector(s) with O-ring, the quick-lock connectors, and the fill line(s) and connectors. If leakage or damage is apparent, see Troubleshooting. " NOTE: If a cuff does not reach or maintain the target pressure value during initial inflation, discontinue using the cuff. See To Switch (or Backup) a Single Cuff. " ALWAYS respond to an alert condition before continuing to use the tourniquet pump. An ALERT symbol, a flashing
• Quantity in Commerce: 1730 units (packs of 10)
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.