REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue)… recallZ-2405-2024 · Stryker Sustainability Solutions · initiated May 31, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Sustainability Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
FDA root cause category: Employee error
What the company is doing
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: [email protected] 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.
Recall details
- Recall number
- Z-2405-2024
- Status
- Open, Classified
- Initiated by the company
- May 31, 2024
- Posted by the FDA
- Jul 17, 2024
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 90 units
- Product code
- KCY
- Distribution
- US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.
Product description
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Code information (models, lots, serial numbers)
Lot: 0000564862/ UDI: 00885825015411
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/AStryker Sustainability Solutions, Inc. · TOURNIQUET, PNEUMATIC1 recall2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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