REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly

FDA device recall Z-2405-2024 · posted 2024-07-17 · Open, Classified

Recall details

Recalling firm

Stryker Sustainability Solutions

Reason for recall

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

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.

Root cause

Employee error

Status

Open, Classified

Product code

KCY

Quantity affected

90 units

Distribution

US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.

Date initiated

2024-05-31

Date posted

2024-07-17

Location

Tempe, AZ