Z-2819-2015Class II

Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model...

Name: Z-2819-2015 Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model...
Creator: Sterilmed, Inc.
Published: 2015-08-24
License: https://open.fda.gov/license/

Sterilmed Inc / initiated 2015-08-24 / Terminated / root cause: labeling and UDI

FDA source

STERILMED, INC. began a recall of Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by... on 2015-08-24. FDA classified it as Class II and gives the reason as "Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside...". 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-2819-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-24
Posted: 2015-09-28
Terminated: 2016-03-11
Recalling firm: Sterilmed Inc
Product: Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Brown (PLC), 34", Model (Reprocessor) Number: ZIM60-7075-106, Reprocessed by Sterilmed. Products are individually packaged in a Tyvek/poly pouch. There are 5 pouches placed inside a casepack box. Each sales unit (casepack) contains 5 devices.
Product code: KCY Tourniquet, Pneumatic
Reason for recall: Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot number 1846885 due to mislabeling. The affected reprocessed product is labeled as single hose devices but the devices inside the packaging are dual hose devices.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: Sterilmed sent an "Urgent Medical Device Recall" letter dated August 24 2015. The letter was addressed to Materials Manger, Risk Manger and Operating Room Supervisor. The letter identified the affected product, problem and actions to be taken. Customers are requested to return all affected product, sign and return the enclosed Customer Response Questionnaire and the Customer Response Form per the instructions on the Forms. For questions contact Sterilmed's Customer Care Team at 888-541-0078.
Quantity in commerce: 43
Distribution: US Nationwide Distribution in the states of CA, KY, MI, OH, UT and WI.
Product codes and lots: Lot 1846885

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2819-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2819-2015	Class II	Terminated	Voluntary: Firm initiated	2015-10-07	2015-09-28

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)