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Recall Observatory FDA recall evidence

Device product

REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly

Z-2405-2024

May 31, 2024

Class II

Product summary

Firm
Stryker Sustainability Solutions
Event
Event 94824
Status
Ongoing
Classification
Class II
Quantity
90 units
Official record key
device-enforcement:Z-2405-2024

Official wording

Reason: Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.

Code information: Lot: 0000564862/ UDI: 00885825015411

Distribution pattern: US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mislabeling