Z-2405-2024Class II

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

Name: Z-2405-2024 REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Creator: Stryker Sustainability Solutions
Published: 2024-05-31
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2024-05-31 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Sustainability Solutions began a recall of REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly on 2024-05-31. FDA classified it as Class II and gives the reason as "Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2405-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-31
Posted: 2024-07-17
Recalling firm: Stryker Sustainability Solutions
Product: REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
Product code: KCY Tourniquet, Pneumatic
Reason for recall: Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 90 units
Distribution: US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.
Product codes and lots: Lot: 0000564862/ UDI: 00885825015411

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2405-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2405-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-17

Product code KCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)