Class 2 Device Recall Stryker 18" (Red), Quick Connect Single Port, single Bladder

• Date Initiated by Firm: January 21, 2022
• Create Date: February 22, 2022
• Recall Status: Terminated on February 26, 2025
• Recall Number: Z-0664-2022
• Recall Event ID: 89535
• Product Classification: Tourniquet, pneumatic - Product Code KCY
• Product: REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
• Code Information: Lot # 12983349
• Recalling Firm/ Manufacturer: Stryker Sustainability Solutions; 1810 W Drake Dr; Tempe AZ 85283-4327
• For Additional Information Contact: Stryker Sustainability Solutions Complaint Hotline; 888-763-8803
• Manufacturer Reason for Recall: Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
• FDA Determined Cause: Labeling mix-ups
• Action: On February 4, 2022, Stryker issued an "Urgent: Medical Device Recall notification" to all affected customers. In addition to informing consignees about the recalled product, the firm ask customers to take the following actions: 1.) Please check your inventory for the devices from the affected lot and remove them from their point of use. 2.) Please complete the Urgent Medical Device Recall Business Reply Form (page 3) and indicate if any of the affected product remains in your inventory. Please return this completed form through one of the following methods: a. Email: SSSPFA@stryker.com b. To your Stryker s Sustainability Solutions Sales Representative c. Fax: 480-763-5345 This form must be completed and returned to Stryker even if no affected product is found. 3.) Maintain awareness of this communication internally until all required actions have been completed within your facility. If any of the affected products have been forwarded to additional facilities (including but not limited to distribution warehouses), please contact these facilities and communicate this recall to them. Please instruct these facilities to complete the Business Reply Form (page 3) and return the completed form either via email to SSSPFA@stryker.com, to their Stryker s Sustainability Solutions sales representative, or via fax to 480-763-5345. Alternatively, provide contact details so Stryker can inform the recipients appropriately. If the form indicates that any affected product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to your facility for all devices that are returned prior to May 1st, 2022. 4.) Adverse reactions or quality problems experienced with the use of this product should be reported to: " Stryker s Sustainability Solutions Complaint Hotline: +1-888-763-8803 " http://www.stryker.com/productexperience " The FDA s MedWatch Adverse Event Reporting program either online, by
• Quantity in Commerce: 40 units
• Distribution: US: KS OK TX OUS: None
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.