PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 6, 2020 Initiated: October 9, 2019 #Z-1802-2020

Product Description

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.

Reason for Recall

Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.

Details

Units Affected
90
Distribution
US Nationwide distribution including the states of SC, TX, UT, NY, AR
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled?
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.. Recalled by Stryker Sustainability Solutions. Units affected: 90.
Why was this product recalled?
Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 6, 2020. Severity: Moderate. Recall number: Z-1802-2020.