FDA recall Z-0132-2024

Product

TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.

Reason for recall

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada and Singapore.

Key facts

Status

Ongoing

Initiation date

2023-09-26

Report date

2023-11-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0132-2024