FDA recall Z-0764-2025

Product

Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RED, Item Number 949000221; 5) FDS,135,NV,MICRO-CHAMBER,W/FILTER,YELLOW, Item Number 949000223

Reason for recall

Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.

Distribution

US Nationwide Distribution

Key facts

Status

Ongoing

Initiation date

2024-12-16

Report date

2025-01-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0764-2025