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Recall Observatory FDA recall evidence

Device product

Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153118

Z-0294-2021

September 14, 2020

Class II

Product summary

Firm
Becton Dickinson & Company
Event
Event 86477
Status
Terminated
Classification
Class II
Quantity
45 units OUS only
Official record key
device-enforcement:Z-0294-2021

Official wording

Reason: Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.

Code information: Lot Number: REEP2920 Exp. Date: Jan-2022 UDI: 00801741141027

Distribution pattern: Foreign: Italy, Spain, and UK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.