Z-1802-2020Class II

Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI...

Name: Z-1802-2020 Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI...
Creator: Stryker Sustainability Solutions
Published: 2019-10-09
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2019-10-09 / Terminated / root cause: manufacturing process

FDA source

Stryker Sustainability Solutions began a recall of Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage... on 2019-10-09. FDA classified it as Class II and gives the reason as "Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1802-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-09
Posted: 2020-04-27
Terminated: 2021-01-14
Recalling firm: Stryker Sustainability Solutions
Product: Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected duration of less than 90 minutes when temporary exsanguination of a limb is desired.
Product code: KCY Tourniquet, Pneumatic
Reason for recall: Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Beginning 10/09/2019, the firm provided an "URGENT MEDICAL DEVICE RECALL" notification letter and attached Recall Effectiveness Check Form to the affected customers through the sales representatives. The notification letter instructed the customer to do the following: (1) Please check inventory for the devices from the affected lot. (2) Complete the Urgent Medical Device Recall Effectiveness Check Form (page 3) and indicate if any of the affected product remains in inventory. Return the completed form through one of the following methods: (a) email; (b) sales representative; or (c) via fax to 480-763-5345. The form must be completed and returned even if no affected product is found. If any of the affected products have been forwarded to additional facilities (including but not limited to distribution warehouses), please contact these facilities and communicate this recall to them. Please instruct these facilities to complete the Recall Effectiveness Check Form (page 3) and return the completed form either via email email, sales representative, or via fax to 480-763-5345. 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 the facility for all devices that are returned prior to January 1, 2020.
Quantity in commerce: 90
Distribution: US Nationwide distribution including the states of SC, TX, UT, NY, AR
Product codes and lots: Lot Number 10237165

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1802-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1802-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-06	2020-04-27

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)