FDA-Device2020-05-06Class II
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.
Hazard
Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
Sold states
US Nationwide distribution including the states of SC, TX, UT, NY, AR
Affected count
90
Manufactured in
1810 W Drake Dr, N/A, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1802-2020More Stryker Sustainability Solutions recalls
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