FDA recall Z-1509-2021

B. Braun Medical, Inc. · Class II · device

Product

Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications.

Reason for recall

BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.

Distribution

US Nationwide distribution in the states of NC, CA.

Key facts

Status
Terminated
Initiation date
2021-03-15
Report date
2021-05-05
Termination date
2022-06-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1509-2021