FDA recall Z-0294-2021

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

Reason for recall

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.

Distribution

Foreign: Italy, Spain, and UK

Key facts

Status

Terminated

Initiation date

2020-09-14

Report date

2020-11-04

Termination date

2021-11-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0294-2021