Recall Z-2405-2024

Reason for recall

Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.

FDA-determined cause: Employee error

Action taken

On June 14, Stryker Sustainability Solutions issued a "Urgent: Medical Device Recall" Notification to affected consignees via mail. Stryker ask consignees to take the following actions: 1) Please check your inventory for the devices from the affected lots and remove them from their point of use. a. 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 to Email: SSSPFA@stryker.com This form must be completed and returned to Stryker even if no affected product is found. 2) Maintain awareness of this communication internally until all required actions have been completed within your facility. 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.