Device product
Bard 3F SL PowerMidline Full 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: P6153208
Z-0295-2021
Product summary
- Event
- Event 86477
- Status
- Terminated
- Classification
- Class II
- Quantity
- 72 units
- Official record key
device-enforcement:Z-0295-2021
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: REEQ3598 Feb-2022 and REER0518 Mar-2022 UDI: 00801741141065
Distribution pattern: Foreign: Italy, Spain, and UK
Derived failure modes
-
Unknown
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.