Z-2348-2015Class II

18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to...

Name: Z-2348-2015 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to...
Creator: Zimmer Surgical Inc
Published: 2015-06-24
License: https://open.fda.gov/license/

Zimmer Surgical SA / initiated 2015-06-24 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Surgical Inc began a recall of 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to... on 2015-06-24. FDA classified it as Class II and gives the reason as "The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2348-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-24
Posted: 2015-08-06
Terminated: 2016-11-04
Recalling firm: Zimmer Surgical SA
Product: 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, Inc. Tourniquets are intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. Single bladder tourniquet cuffs are generally used for operations lasting less than 90 minutes.
Product code: KCY Tourniquet, Pneumatic
Reason for recall: The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions and warnings.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Zimmer sent an Urgent Medical Device Correction letter dated June 30, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review the notification, identify the affected product and replace the IFU with the enclosed corrected IFU. Customers were also instructed to complete the attached Response Form and return it via email to [email protected]. Customers with questions were instructed to call 330-364-0989.
Quantity in commerce: 61 units
Distribution: Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV & WY and Internationally to Canada.
Product codes and lots: Item 60707000300, Lot Z000002044

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2348-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2348-2015	Class II	Terminated	N/A	2015-08-12	2015-08-06
Z-2349-2015	Class II	Terminated	N/A	2015-08-12	2015-08-06

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)